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		<title>Eli Lilly&#8217;s obesity pill will rival Novo Nordisk&#8217;s oral Wegovy drug</title>
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		<pubDate>Sun, 24 Aug 2025 14:37:40 +0000</pubDate>
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					<description><![CDATA[<p>A sign with the company logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024. Scott Olson &#124; Getty Images Eli Lilly&#8216;s stock is still recovering after the drugmaker released trial data earlier this month on its closely watched obesity pill that underwhelmed Wall Street. In a key late-stage trial, [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/eli-lillys-obesity-pill-will-rival-novo-nordisks-oral-wegovy-drug/">Eli Lilly&#8217;s obesity pill will rival Novo Nordisk&#8217;s oral Wegovy drug</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0"/></p>
<p>A sign with the company logo sits outside of the headquarters of Eli Lilly in Indianapolis, Indiana, on March 17, 2024.</p>
<p>Scott Olson | Getty Images</p>
<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Eli Lilly<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s stock is still recovering after the drugmaker released trial data earlier this month on its closely watched obesity pill that underwhelmed Wall Street.</p>
<p>In a key late-stage trial, Eli Lilly&#8217;s pill, orforglipron, caused less weight loss and had higher side effects than what analysts were expecting. The pill&#8217;s efficacy also appeared to come in slightly below that of <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-4">Novo Nordisk<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s oral semaglutide for obesity, which showed strong data in a separate study.</p>
<p>Shares of Eli Lilly fell about 13% on the day the trial results were released, although they&#8217;re up about 12% since then.</p>
<p>But some analysts say Eli Lilly&#8217;s daily pill, if approved, could still be a viable competitor in the weight loss drug space — even if it will likely be second to enter the market. It&#8217;s a highly lucrative area that is eager for more convenient options that could ease the supply shortfalls and access hurdles created by the pricey weekly injections currently dominating it.</p>
<p>Analysts note that Eli Lilly&#8217;s pill could have a few advantages over the daily oral version of Novo Nordisk&#8217;s weight loss drug semaglutide, which is on track to become the first needle-free alternative for obesity to win approval in the U.S. later this year. Eli Lilly hopes to launch its pill globally &#8220;this time next year,&#8221; CEO David Ricks told CNBC in early August.</p>
<p>Both drugs work by mimicking a gut hormone called GLP-1 to suppress appetite and regulate blood sugar. But while Novo Nordisk&#8217;s pill is a peptide medication, orforglipron is a small-molecule drug.</p>
<p>That means Eli Lilly&#8217;s pill is absorbed more easily in the body and doesn&#8217;t require dietary restrictions like Novo Nordisk&#8217;s does. Orforglipron will also be easier to manufacture at scale, which is crucial as demand for obesity and diabetes injections outpaces supply.</p>
<p>Neither company has released prices for its respective pill, but some analysts said Eli Lilly&#8217;s drug could potentially have a lower price than Novo Nordisk&#8217;s pill. That would be a notable edge, as many health plans in the U.S. still don&#8217;t cover obesity treatments.</p>
<p>&#8220;It&#8217;s a little bit of an apples and oranges comparison because Novo Nordisk could have difficulty manufacturing enough of the product, given the high cost and requirements to manufacture oral semaglutide,&#8221; Leerink Partners analyst David Risinger said in an interview. </p>
<p>&#8220;Whereas Lilly plans to blanket the world with orforglipron, and very quickly it will generate dramatically more sales,&#8221; he continued. &#8220;It can launch globally in an extraordinary manner with lower prices and with no food intake consideration.&#8221;</p>
<p>Goldman Sachs analysts seem to agree, based on a note in August. They forecast daily oral pills will capture 24% share — or around $22 billion — of the 2030 global weight loss drug market, which they expect to be worth $95 billion. </p>
<p>The Goldman analysts said they expect Eli Lilly&#8217;s pill to have a 60% share — or roughly $13.6 billion — of the daily oral segment of the market in 2030. They expect Novo Nordisk&#8217;s oral semaglutide to have a 21% share — or around $4 billion — of that segment. The remaining 19% slice will go to other emerging pills, the analysts said.</p>
<p>The race to develop a more convenient obesity pill has been fraught, as companies such as <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-7">Pfizer<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span> have had to scrap previous contenders and bring forward new ones. Novo Nordisk and Eli Lilly are also exploring other experimental oral drugs, along with a slate of other companies such as <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-9">Viking Therapeutics<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>, <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-10">Structure Therapeutics<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>, <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-11">AstraZeneca<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span> and <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-12">Roche<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>. </p>
<p>In a statement, Novo Nordisk CEO Mike Doustar said &#8220;we strongly believe in the efficacy&#8221; of the oral drug. The Danish company added it will be &#8220;laser-focused on getting this product to patients without supply constraints&#8221; in the U.S. </p>
<p>Dr. Mihail &#8220;Misha&#8221; Zilbermint, director of endocrine hospitalists at Johns Hopkins Community Physicians, said it&#8217;s hard to crown a winner between Eli Lilly and Novo Nordisk without knowing how their respective pills will be priced and whether insurance will cover them. </p>
<p>&#8220;I think both of the drugs are going to be gamechangers,&#8221; he said. &#8220;When it comes to which company is going to win the game — cost is the biggest issue.&#8221;</p>
<h2 class="ArticleBody-subtitle">Weight loss, side effect comparisons</h2>
<p>It&#8217;s difficult to directly compare the results of separate clinical trials, especially as investors wait for Eli Lilly and Novo Nordisk to release the full data from their phase three studies.</p>
<p>Eli Lilly&#8217;s ATTAIN-1 trial also followed 3,000 patients, while Novo Nordisk&#8217;s OASIS 4 study evaluated a much smaller group of roughly 300. There are currently no studies directly comparing the two drugs, a Novo Nordisk spokesperson said.</p>
<p>But Novo Nordisk&#8217;s oral semaglutide appears to cause a greater level of weight loss than Eli Lilly&#8217;s pill based on the available data, said BMO Capital Markets analyst Evan Seigerman. </p>
<p>In the trial, the highest dose of Eli Lilly&#8217;s pill helped patients lose 12.4% of their body weight on average at 72 weeks. The pill&#8217;s weight loss was 11.2% when analyzing all patients regardless of discontinuations.</p>
<p>Wall Street had hoped Eli Lilly&#8217;s pill would generate weight loss of around 15%, the same level as Novo Nordisk&#8217;s blockbuster weight loss injection Wegovy. Semaglutide is the active ingredient in Wegovy and its diabetes counterpart Ozempic. </p>
<p>Novo Nordisk flags flutter outside its office in Bagsvaerd, on the outskirts of Copenhagen, Denmark, on July 14, 2025.</p>
<p>Tom Little | Reuters</p>
<p>Meanwhile, the 25-milligram dose of Novo Nordisk&#8217;s oral semaglutide helped patients lose up to 16.6% of their weight on average at 64 weeks, according to results from the trial presented at a medical conference in 2024. That weight loss was 13.6% when the company analyzed all patients regardless of whether they stopped the drug. </p>
<p>A Novo Nordisk spokesperson added that 20% of weight loss was observed in nearly one-third of patients in the trial.</p>
<p>Still, the slightly lower efficacy of Eli Lilly&#8217;s pill may not be significant enough to deter patients from taking it. </p>
<p>&#8220;For many patients, 12% is a really great number,&#8221; said Seigerman. &#8220;There&#8217;s definitely a market there&#8221; for orforglipron.</p>
<p>In a note earlier this month, Bank of America analysts shared a similar sentiment. </p>
<p>&#8220;Yes, weight loss fell a bit short, but ask 100 prescribers whether this new data will really make a difference in who they&#8217;d put on orforglipron, and our belief is the vast majority would say, &#8216;not really,'&#8221; they wrote, referring to Eli Lilly&#8217;s trial data. </p>
<p>Some investors raised concerns about the side effects and discontinuation rates in the trial of Eli Lilly&#8217;s pill. But Seigerman said the drug&#8217;s tolerability data — how well patients tolerate it — appears to be relatively in line with that of Novo Nordisk&#8217;s oral semaglutide. </p>
<p>About 10.3% of patients who took the highest dose of Eli Lilly&#8217;s pill — 36 milligrams — discontinued treatment due to side effects, compared with around 2.6% of those who took a placebo.</p>
<p>Those side effects were mainly gastrointestinal, such as nausea and vomiting, and mild to moderate in severity. An estimated 24% of those who took the highest dose of Eli Lilly&#8217;s pill reported vomiting, while 33.7% had nausea. </p>
<p>Leerink&#8217;s Risinger said he is watching to see how persistent those gastrointestinal issues are once Eli Lilly presents the full data. </p>
<p>The side effects in the trial on Novo Nordisk&#8217;s pill were mostly gastrointestinal-related: 30.9% of those who took oral semaglutide reported vomiting and 46.6% reported nausea, according to the trial results. </p>
<p>Johns Hopkins&#8217; Zilbermint said it&#8217;s difficult for him to decide which one has a better safety and tolerability profile based on the available data. </p>
<p>Meanwhile, Seigerman pointed to a different factor &#8220;that will also matter a lot&#8221;: dietary requirements. </p>
<h2 class="ArticleBody-subtitle">Food requirements, manufacturing, price </h2>
<p>Unlike Eli Lilly&#8217;s pill, patients need to take Novo Nordisk&#8217;s oral semaglutide in the morning on an empty stomach with no more than four ounces of plain water. They&#8217;re instructed to wait 30 minutes before eating, drinking or taking other oral medicines.</p>
<p>Seigerman said that could be a hurdle for some patients. </p>
<p>For example, &#8220;if you&#8217;re a parent with kids and you have to take this drug and wait half an hour before you can drink your coffee, you&#8217;re going to drive yourself crazy, especially if you have to take this every day,&#8221; he said. &#8220;I try to think about the real-world use of these drugs in a market like this. It&#8217;s going to matter.&#8221; </p>
<p>Leerink&#8217;s Risinger said oral semaglutide will also be &#8220;extremely expensive to manufacture&#8221; since it is a peptide medication, and &#8220;is likely going to have to be priced higher than orforlipgron.&#8221;</p>
<p>A Novo Nordisk spokesperson said the pill will be made mostly in the U.S., and the company is excited about the potential the pill &#8220;provides millions of Americans living with obesity.&#8221;</p>
<p>&#8220;Currently, all typical launch readiness activities [for the pill] are fully underway and building momentum,&#8221; the spokesperson said. They added that over the past decade, the company has invested $24 billion in the U.S. to expand manufacturing capacity and fuel research and development. That includes investments aimed at increasing manufacturing of active pharmaceutical ingredients and capacity for the final stages of production for both current and future injectable and oral products. </p>
<p>Small molecules are chemically simpler and easier to produce at scale, making them generally cheaper for companies to formulate. But it is still unclear how Eli Lilly will price orforglipron. </p>
<p>During an earnings call in August, Eli Lilly&#8217;s Ricks said the pricing will be based on the value orforglipron brings, considering health-care savings and the comorbidities it can address.</p>
<p>In the note earlier this month, Goldman Sachs analysts said they expect the pill to be &#8220;priced at parity&#8221; to Eli Lilly&#8217;s tirzepatide, the active ingredient in the company&#8217;s obesity injection Zepbound and diabetes counterpart Mounjaro, which list for just over $1,000 for a month&#8217;s supply. </p>
<p>&#8220;They should be cheaper than injections because they are easier to produce. But it does not mean they will be cheaper,&#8221; Johns Hopkins&#8217; Zilbermint said. &#8220;We just don&#8217;t know — for example, we don&#8217;t know how much went into research and development.&#8221;</p>
<p>Seigerman said commercialization strategies will also be key when the pills compete on the market. </p>
<p>He questioned whether Novo Nordisk will lean into the deal it recently struck with <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-14">CVS<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s pharmacy benefit manager, Caremark. Under the deal, Caremark started to prioritize Novo Nordisk&#8217;s Wegovy on its standard formularies on July 1, making that weekly injection the preferred GLP-1 drug for obesity over Zepbound. </p>
<p>But it is unclear whether oral semaglutide could receive a similar preferential status.</p>
<p>Seigerman also questioned whether Eli Lilly will offer orforglipron through its direct-to-consumer pharmacy, LillyDirect. That offering bypasses insurers and pharmacy benefit managers, allowing patients to directly purchase Zepbound and some of Eli Lilly&#8217;s other drugs from the company. </p>
<p>Seigerman said he expects &#8220;a lot of nuances in the go-to-market campaign for these drugs,&#8221; adding &#8220;that&#8217;s going to matter.&#8221;</p>
<h2 class="ArticleBody-subtitle">Other competitors trail behind</h2>
<p>Other obesity pills are in earlier stages of development, making it difficult to directly compare them to the drugs from Eli Lilly and Novo Nordisk without longer and larger trials. </p>
<p>But so far, some experts think they pale in comparison.</p>
<p>For example, Viking Therapeutics on Tuesday released mid-stage trial data that disappointed investors, sending its stock down as much as 40%. </p>
<p>Jared Holz, Mizuho health care equity strategist, said in an email Tuesday that the results on Viking&#8217;s drug &#8220;look inferior&#8221; to those of Eli Lilly&#8217;s pill &#8220;on almost all metrics.&#8221; </p>
<p>Viking&#8217;s once-daily pill helped patients lose up to 12.2% of their weight at around three months, with no plateau, which means patients could lose even more in a longer-term study.</p>
<p>Holz pointed to the high rate of patients who discontinued Viking&#8217;s drug for any reason over 13 weeks, which was around 28%. Meanwhile, around a quarter of people discontinued Eli Lilly&#8217;s pill, orforglipron, for any reason over 72 weeks.</p>
<p>That&#8217;s &#8220;a much longer trial and therefore [Lilly] looks far better head-to-head,&#8221; Holz said.</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/eli-lillys-obesity-pill-will-rival-novo-nordisks-oral-wegovy-drug/">Eli Lilly&#8217;s obesity pill will rival Novo Nordisk&#8217;s oral Wegovy drug</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>Medicare can cover Eli Lilly&#8217;s Zepbound for sleep apnea: Health Department agency</title>
		<link>https://www.ourstoryinsight.com/medicare-can-cover-eli-lillys-zepbound-for-sleep-apnea-health-department-agency/</link>
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		<dc:creator><![CDATA[admin]]></dc:creator>
		<pubDate>Fri, 10 Jan 2025 09:53:44 +0000</pubDate>
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					<description><![CDATA[<p>An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City on Dec. 11, 2023. Brendan McDermid &#124; Reuters Medicare drug plans can now cover Eli Lilly&#8216;s blockbuster obesity drug Zepbound for obstructive sleep apnea, CNBC confirmed on Wednesday.  That opens the door for broader access to Zepbound, which is [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/medicare-can-cover-eli-lillys-zepbound-for-sleep-apnea-health-department-agency/">Medicare can cover Eli Lilly&#8217;s Zepbound for sleep apnea: Health Department agency</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0"/></p>
<p>An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City on Dec. 11, 2023.</p>
<p>Brendan McDermid | Reuters</p>
<p>Medicare drug plans can now cover <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Eli Lilly<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s blockbuster obesity drug Zepbound for obstructive sleep apnea, CNBC confirmed on Wednesday. </p>
<p>That opens the door for broader access to Zepbound, which is not currently covered by Medicare and many other insurance plans for weight loss. Demand for the injection has soared over the last year despite its roughly $1,000 per month price tag before insurance.</p>
<p>In a statement to CNBC, a spokesperson for the Centers for Medicare &#038; Medicaid Services, an agency of the U.S. Department of Health and Human Services, said &#8220;current Medicare Part D and Medicaid coverage rules apply&#8221; to Zepbound following its landmark approval in December for the most common sleep-related breathing disorder.</p>
<p>Medicare Part D plans can only cover obesity drugs if they are used for an additional medically accepted purpose approved by the Food and Drug Administration, the CMS spokesperson said, referring to the agency&#8217;s guidance. The spokesperson added that Part D plans may consider using prior authorization — a process where a provider must first get approval from an insurer — for those drugs to ensure they are being used for that specific purpose. </p>
<p>The FDA on Dec. 20 cleared Zepbound for patients with obesity and moderate-to-severe forms of obstructive sleep apnea, or OSA, which refers to breathing interrupted during sleep due to narrowed or blocked airways. That made Zepbound the first drug treatment cleared for the estimated 20 million people with those forms of the disease, according to Eli Lilly.</p>
<p>In a statement on Thursday, Eli Lilly called Medicare&#8217;s coverage of Zepbound for the condition &#8220;good news.&#8221; </p>
<p>Medicare Part D plans are similarly allowed to cover <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-8">Novo Nordisk<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s weight loss drug Wegovy for its other approved use: lowering cardiovascular risks. The diabetes counterparts of Wegovy and Zepbound — Ozempic and Mounjaro, respectively — are covered by Medicare and most insurance plans. </p>
<p>Both Novo Nordisk and Eli Lilly are studying their weight loss medicines as treatments for fatty liver disease, chronic kidney disease, sleep apnea and more. To be covered, those drugs would need to return late-stage trial results and then be submitted for FDA approval for those uses.</p>
<p>Meanwhile, state Medicaid coverage for Zepbound and other obesity medications depends on what condition they are prescribed for and whether their manufacturer has signed a certain Medicaid drug rebate agreement, according to the spokesperson. </p>
<p>Under that agreement with the secretary of Health and Human Services, manufacturers agree to provide rebates to states in exchange for Medicaid coverage of their drugs. States share the rebates with the federal government. </p>
<p>A state Medicaid program must cover Zepbound if it is prescribed for OSA and Eli Lilly has signed the Medicaid drug rebate agreement, the spokesperson said. </p>
<p>But if Zepbound is prescribed for weight loss, state Medicaid programs are not required to cover it. </p>
<p>The Biden administration in November proposed a rule that would allow Medicare and Medicaid to cover weight loss drugs for patients with obesity. The rule would give millions of people access to weekly injectables, but it would cost taxpayers as much as $35 billion over the next decade.</p>
<p>It is unclear if President-elect Donald Trump&#8217;s administration will pursue the rule.</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/medicare-can-cover-eli-lillys-zepbound-for-sleep-apnea-health-department-agency/">Medicare can cover Eli Lilly&#8217;s Zepbound for sleep apnea: Health Department agency</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>FDA approves Eli Lilly&#8217;s weight loss drug Zepbound for sleep apnea</title>
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		<pubDate>Sat, 21 Dec 2024 08:17:31 +0000</pubDate>
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					<description><![CDATA[<p>An Eli Lilly &#038; Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.  Shelby Knowles &#124; Bloomberg &#124; Getty Images The Food and Drug Administration on Friday approved Eli Lilly&#8216;s blockbuster weight loss drug Zepbound for treating patients with the most common sleep-related breathing disorder, expanding [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-eli-lillys-weight-loss-drug-zepbound-for-sleep-apnea/">FDA approves Eli Lilly&#8217;s weight loss drug Zepbound for sleep apnea</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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<p>An Eli Lilly &#038; Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024. </p>
<p>Shelby Knowles | Bloomberg | Getty Images</p>
<p>The Food and Drug Administration on Friday approved <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Eli Lilly<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s blockbuster weight loss drug Zepbound for treating patients with the most common sleep-related breathing disorder, expanding its use and possibly its insurance coverage in the U.S.</p>
<p>The weekly injection is now the first drug treatment option cleared for patients with obesity and moderate-to-severe obstructive sleep apnea, or OSA, which refers to breathing interrupted during sleep due to narrowed or blocked airways. Zepbound should be used in combination with a reduced-calorie diet and increased physical activity, the FDA noted in a release. </p>
<p>An estimated 80 million patients in the U.S. experience the disease, according to Eli Lilly. Roughly 20 million of those people have moderate-to-severe forms of the disease, but 85% of cases go undiagnosed, the company told CNBC earlier this year.</p>
<p>&#8220;Too often, OSA is brushed off as &#8216;just snoring&#8217; — but it&#8217;s far more than that,&#8221; said Julie Flygare, president and CEO of Project Sleep, a nonprofit advocating for sleep health and sleep disorders, in a release from Eli Lilly. &#8220;It&#8217;s important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.&#8221; </p>
<p>Eli Lilly expects to launch the drug for OSA at the beginning of next year. It is the first approval beyond obesity treatment for Zepbound, which entered the market late last year and is also being tested for several other obesity-related conditions, such as fatty liver disease. Tirzepatide, the active ingredient in Zepbound, has been sold on the U.S. market for longer as the diabetes drug Mounjaro.</p>
<p>The agency&#8217;s decision could pave the way for Eli Lilly to gain broader insurance coverage for Zepbound, which, like other weight loss drugs, is not covered by many insurance plans. That includes the federal Medicare program, which only covers obesity drugs if they are approved and prescribed for an added health benefit.</p>
<p>The approval also backs up mounting evidence that there could be further health benefits tied to GLP-1s, a class of weight loss and diabetes treatments that have soared in popularity and slipped into shortages over the past year. Notably, Zepbound&#8217;s main rival, the weight loss drug Wegovy from <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-6">Novo Nordisk<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>, is not approved for OSA.</p>
<p>Zepbound could be a valuable new treatment option for patients with OSA, which can lead to loud snoring and excessive daytime sleepiness, and can contribute to serious complications including stroke and heart failure. Patients with the condition have limited treatment options outside of wearing masks hooked up to cumbersome machines that provide positive airway pressure, or PAP, to allow for normal breathing.</p>
<p>Eli Lilly in April released initial results from the two clinical trials, which showed that Zepbound was more effective than a placebo at reducing the severity of OSA in patients with obesity after a year.</p>
<p>In June, Eli Lilly released additional data from the studies showing that Zepbound helped<br />resolve OSA in almost half of patients. The first study examined the weekly injection in adults with moderate-to-severe OSA and obesity who were not on PAP therapy. The second tested Zepbound in adults with the same conditions, but those participants were on and planned on continuing PAP therapy.</p>
<p>The data showed that 43% of people in the first study and 51.5% of patients in the second trial who took the highest dose of Zepbound achieved &#8220;disease resolution,&#8221; according to the company. That compares with 14.9% and 13.6% of patients who took a placebo in the two trials, respectively.</p>
<p>Researchers came to those conclusions by examining an apnea-hypopnea index, or AHI, which records the number of times per hour a person&#8217;s breathing shows a restricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.</p>
<p>Disease resolution for OSA is defined as a patient having fewer than five AHI events per hour, the company said. It is also defined as a person having five to 14 AHI events per hour and scoring a certain number on a standard survey designed to measure excessive daytime sleepiness, according to Eli Lilly.</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-eli-lillys-weight-loss-drug-zepbound-for-sleep-apnea/">FDA approves Eli Lilly&#8217;s weight loss drug Zepbound for sleep apnea</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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