{"id":374592,"date":"2021-12-01T01:22:00","date_gmt":"2021-11-30T22:22:00","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/fda-advisers-recommend-mercks-covid-19-pill-in-close-vote\/"},"modified":"2021-12-01T01:22:00","modified_gmt":"2021-11-30T22:22:00","slug":"fda-advisers-recommend-mercks-covid-19-pill-in-close-vote","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/fda-advisers-recommend-mercks-covid-19-pill-in-close-vote\/","title":{"rendered":"#: FDA advisers recommend Merck\u2019s COVID-19 pill in close vote"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a39b7aea8004\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #dd3333;color:#dd3333\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #dd3333;color:#dd3333\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a39b7aea8004\" checked aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/buradabiliyorum.com\/en\/fda-advisers-recommend-mercks-covid-19-pill-in-close-vote\/#Panel_narrowly_endorses_molnupiravir_which_would_be_first_COVID-19_pill_to_be_taken_at_home\" >Panel narrowly endorses molnupiravir, which would be first COVID-19 pill to be taken at home<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/buradabiliyorum.com\/en\/fda-advisers-recommend-mercks-covid-19-pill-in-close-vote\/#Jaimy_Lee\" >Jaimy Lee<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<p>&#8220;<strong>#: FDA advisers recommend Merck\u2019s COVID-19 pill in close vote<\/strong>&#8221;<\/p>\n<h2 class=\"article__subhead\" itemprop=\"alternativeHeadline\"><span class=\"ez-toc-section\" id=\"Panel_narrowly_endorses_molnupiravir_which_would_be_first_COVID-19_pill_to_be_taken_at_home\"><\/span>\n  Panel narrowly endorses molnupiravir, which would be first COVID-19 pill to be taken at home<br \/>\n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><\/p>\n<div class=\"column column--full article__content\" role=\"region\" aria-label=\"article body\">\n<div class=\"article__side\">\n<div class=\"container--sticky not-active\">\n<div id=\"cx-next\" data-nosnippet>\n              <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div id=\"js-article__body\" class=\"article__body article-wrap at16-col16 barrons-article-wrap\" itemprop=\"articleBody\" data-sbid=\"WP-MKTW-0000502698\" role=\"document\">\n<div class=\"barrons-article-ad-wrapper\">\n<div data-track=\"barrons-article-ad-wrap\" class=\"barrons-article-ad sticky_item\">\n<div class=\"barrons-main-article-ad-target sticky_target body_ad\" aria-hidden=\"true\"><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div data-layout=\"\n                inline\" data-layout-mobile=\"\" class=\"\n          media-object\n          type-InsetArticleReader\n              \n              inline\n  article__inset\n          article__inset--type-InsetArticleReader\n              article__inset--inline\n  \"><\/p>\n<div class=\"media-object-article-reader\">\n<div class=\"audioplayer\" data-sbid=\"WP-MKTW-0000502698\" role=\"region\" aria-label=\"Listen to Article\" tabindex=\"-1\" id=\"articlereader\" data-show-title=\"false\" data-theme=\"wsj-article-reader\" data-show-header=\"false\" data-show-subscribe=\"false\" data-ads-enabled=\"true\" data-save-publication=\"false\">\n        <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<p>       The Food and Drug Administration advisory committee said Tuesday the benefits of Merck &amp; Co.\u2019s experimental antiviral COVID-19 pill outweigh its risks in a 13-10 vote, with several advisors saying they had concerns about use of the drug in pregnant women.<\/p>\n<p> Shares of Merck<br \/>\n        MRK,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/209956077\/composite\" class=\"positive\">+0.03%<\/bg-quote><br \/>\n       rose 2% in after-hours trading on Tuesday after ending the regular trading day  up a fraction. The company is developing the pill, which is called molnupiravir, with privately held Ridgeback Biotherapeutics.<\/p>\n<div class=\"paywall\">\n       The FDA is now expected to deliver its final decision, likely before the end of the year. The regulator often takes into account the recommendation of its advisory committees but is not required to do so.\u00a0<\/p>\n<p>If molnupiravir is authorized by the FDA in the coming weeks, as expected, the treatment will be the first oral COVID-19 pill that patients can take at home.<\/p>\n<p>Members of the Antimicrobial Drugs Advisory Committee also suggested a safety-monitoring program, expressed concerns about prescribing the drug to those who are immunocompromised, and shared their concerns about the overall efficacy of the pill. <\/p>\n<p>Some Wall Street analysts had predicted that the advisors would vote in support of authorization but with a cautious <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/download-scripts-themes-apps\/\" data-internallinksmanager029f6b8e52c=\"9\" title=\"Download Scripts &amp; Themes &amp; Apps\" target=\"_blank\" rel=\"noopener\">app<\/a>roach. <\/p>\n<p>\u201cDespite these reservations, molnupiravir is also likely to be approved, and demand is likely to exceed their 20 [million] course supply in 2022,\u201d SVB Leerink analysts wrote on Friday.<\/p>\n<p>Of the COVID-19 treatments that are currently available, most are used to care for very sick, hospitalized people. This includes the steroid dexamethasone and Gilead <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/sciencee\/\" data-internallinksmanager029f6b8e52c=\"5\" title=\"Science\" target=\"_blank\" rel=\"noopener\">Science<\/a>s Inc.\u2019s<br \/>\n        GILD,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/210293917\/composite\" class=\"negative\">-2.43%<\/bg-quote><br \/>\n       Veklury. <\/p>\n<p>The monoclonal antibodies developed by Eli Lilly &amp; Co.<br \/>\n        LLY,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/200106384\/composite\" class=\"negative\">-2.66%<\/bg-quote><span>,<\/span><br \/>\n       Regeneron Pharmaceuticals Inc.<br \/>\n        REGN,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/203149337\/composite\" class=\"negative\">-2.73%<\/bg-quote><span>,<\/span><br \/>\n       and Vir Bio<a href=\"https:\/\/buradabiliyorum.com\/en\/category\/technology\/\" data-internallinksmanager029f6b8e52c=\"4\" title=\"Technology\" target=\"_blank\" rel=\"noopener\">technology<\/a> Inc.<br \/>\n        VIR,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/214486077\/composite\" class=\"positive\">+17.14%<\/bg-quote><br \/>\n       and GlaxoSmithKline<br \/>\n        GSK,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/209463850\/composite\" class=\"negative\">-0.58%<\/bg-quote><br \/>\n       can be used to treat people with mild or moderate cases of COVID-19, but these treatments have to be administered by an infusion in a clinical setting.<\/p>\n<p>Molnupiravir was once held as a <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/game\/\" data-internallinksmanager029f6b8e52c=\"7\" title=\"Game\" target=\"_blank\" rel=\"noopener\">game<\/a> changer in the course of the pandemic, but its importance has shifted as new data from the clinical trial came out and a competitor stepped up. <\/p>\n<div id=\"cx-membership-tile\"><\/div>\n<p>Wall Street\u2019s interest in Merck\u2019s pill began to wane in November when Pfizer Inc.<br \/>\n        PFE,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/202877789\/composite\" class=\"positive\">+2.54%<\/bg-quote><br \/>\n       produced even more compelling results for its COVID-19 drug candidate, demonstrating that Paxlovid reduced the risk of hospitalization and death by a stunning 89% in a clinical trial. The company filed for emergency authorization later in the month. <\/p>\n<p>Then, last week, Merck shared that its pill reduced the risk of hospitalization and death by 30% in a clinical trial\u2014and not 50% as reported in the interim results. Wall Street is now factoring in growing worries about the omicron variant and the continuing need for new and better treatments for COVID-19.<\/p>\n<p>\u201cConcerns over the new omicron variant are increasing expectations on the potential of Pfizer\u2019s COVID-19 vaccine Comirnaty and updated data from Merck\u2019s oral anti-viral molnupiravir are increasing expectations for Pfizer\u2019s anti-viral\u00a0Paxlovid,\u201d Mizuho Securities analysts told investors on Monday.<\/p>\n<p>Analysts were once over the moon about the sales potential of the first oral COVID-19 pill that works, predicting between $5 billion and $7 billion in sales next year alone. But the arrival of new efficacy data dragged down interest in both the drug and Merck\u2019s stock. <\/p>\n<p>Citi on Monday downgraded Merck\u2019s stock to neutral, from buy, citing concerns about the company\u2019s experimental HIV drug islatravir and about molnupiravir.\u00a0<\/p>\n<p>Merck is seeking authorization for molnupiravir in adults who have tested positive for the virus, are experiencing mild or moderate symptoms, and are at high risk for severe disease.\u00a0Patients are expected to start treatment within five days of symptoms.<\/p>\n<p>The Phase 2\/3, randomized, placebo-controlled, double-blind <a rel=\"nofollow noopener\" target=\"_blank\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04575597\" class=\"icon none\">study<\/a> only enrolled people who were unvaccinated; however, it\u2019s unclear whether the pill could be used to treat vaccinated individuals with breakthrough infections if it is authorized.\u00a0<\/p>\n<p>Molnupiravir has already been authorized for use in the U.K.<\/p>\n<p><strong>Read more coverage about Merck and its COVID-19 pill:\u00a0<\/strong><\/p>\n<p>Merck stock dives after Citi downgrades on \u2018high probability\u2019 that HIV treatment will be abandoned<\/p>\n<p>Merck\u2019s COVID-19 pill could bring in up to $7 billion in sales next year<\/p>\n<p>Why a pill you take at home could change the direction of the pandemic<\/p><\/div>\n<\/div><\/div>\n<p><\/p>\n<div class=\"byline article__byline\">\n<p>    <span>By<\/span><\/p>\n<div class=\"author mobile-scrim hasMenu\" data-scrim='{\"type\":\"author\",\"header\":\"Jaimy Lee\",\"subhead\":\"The Wall Street Journal\",\"list\":[{\"type\":\"link\",\"icon\":\"bio\",\"url\":\"https:\/\/www.marketwatch.com\/topics\/journalists\/jaimy-lee\",\"text\":\"Biography\"},{\"type\":\"link\",\"icon\":\"twitter\",\"url\":\"https:\/\/twitter.com\/jaimy_lee\",\"text\":\"@jaimy_lee\"}]}' itemscope itemprop=\"author\" itemtype=\"http:\/\/schema.org\/Person\">\n<h4 itemprop=\"name\"><span class=\"ez-toc-section\" id=\"Jaimy_Lee\"><\/span>Jaimy Lee<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<\/p><\/div>\n<\/div>\n<p><script async src=\"https:\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><\/p>\n<blockquote><p><strong><span style=\"color: #ff6600;\">If you liked the article, do not forget to share it with your friends. 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