{"id":1659,"date":"2024-03-08T14:06:17","date_gmt":"2024-03-08T15:06:17","guid":{"rendered":"https:\/\/medexperts.pro\/?p=1659"},"modified":"2024-03-12T21:03:40","modified_gmt":"2024-03-12T21:03:40","slug":"a-l-s-drug-relyvrio-fails-clinical-trial-and-may-be-withdrawn-from-the-market","status":"publish","type":"post","link":"https:\/\/medexperts.pro\/?p=1659","title":{"rendered":"A.L.S. Drug Relyvrio Fails Clinical Trial and May Be Withdrawn From the Market"},"content":{"rendered":"
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Leaders of the treatment\u2019s manufacturer, Amylyx, said they would announce their plans for it within eight weeks.<\/p>\n

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One of the few treatments the Food and Drug Administration has approved for amyotrophic lateral sclerosis has failed a large clinical trial, and its manufacturer said Friday that it was considering whether to withdraw it from the market.<\/p>\n

The medication, called Relyvrio, was approved less than two years ago<\/a>, despite questions about its effectiveness in treating the severe neurological disorder. At the time, the F.D.A.\u2019s reviewers had concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance.<\/p>\n

But the agency decided to greenlight the medication instead of waiting two years for results of a large clinical trial, citing data showing the treatment to be safe and the desperation of patients with a disease that often causes death within two to five years. Since then, about 4,000 patients in the United States have received the treatment, a powder that is mixed with water and either drunk or ingested through a feeding tube and carries a list price of $158,000 a year<\/a>.<\/p>\n

Now, results of the 48-week trial of 664 patients are in, and they showed that the treatment did not work better than a placebo.<\/p>\n<\/div>\n<\/div>\n

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\u201cWe are surprised and deeply disappointed,\u201d Justin Klee and Joshua Cohen, the co-chief executive officers of Amylyx Pharmaceuticals, the treatment\u2019s manufacturer, said in a statement. They said they would announce their plans for the medication within eight weeks, \u201cwhich may include voluntarily withdrawing\u201d it from the market.<\/p>\n

\u201cWe will be led in our decisions by two key principles: doing what is right for people living with A.LS., informed by regulatory authorities and the A.L.S. community, and by what the science tells us,\u201d Mr. Klee and Mr. Cohen said.<\/p>\n

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Leaders of the treatment\u2019s manufacturer, Amylyx, said they would announce their plans for it within eight weeks.One of the few treatments the Food and Drug Administration has approved for amyotrophic lateral sclerosis has failed a large clinical trial, and its manufacturer said Friday that it was considering whether to withdraw it from the market.The medication, called Relyvrio, was approved less than two years ago, despite questions about its effectiveness in treating the severe neurological disorder. At the time, the F.D.A.\u2019s reviewers had concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance.But the agency decided to greenlight the medication instead of waiting two years for results of a large clinical trial, citing data showing the treatment to be safe and the desperation of patients with a disease that often causes death within two to five years. Since then, about 4,000 patients in the United States have received the treatment, a powder that is mixed with water and either drunk or ingested through a feeding tube and carries a list price of $158,000 a year.Now, results of the 48-week trial of 664 patients are in, and they showed that the treatment did not work better than a placebo.\u201cWe are surprised and deeply disappointed,\u201d Justin Klee and Joshua Cohen, the co-chief executive officers of Amylyx Pharmaceuticals, the treatment\u2019s manufacturer, said in a statement. They said they would announce their plans for the medication within eight weeks, \u201cwhich may include voluntarily withdrawing\u201d it from the market.\u201cWe will be led in our decisions by two key principles: doing what is right for people living with A.LS., informed by regulatory authorities and the A.L.S. community, and by what the science tells us,\u201d Mr. Klee and Mr. Cohen said.We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and\u00a0log into\u00a0your Times account, or\u00a0subscribe\u00a0for all of The Times.Thank you for your patience while we verify access.Already a subscriber?\u00a0Log in.Want all of The Times?\u00a0Subscribe.<\/p>\n","protected":false},"author":1,"featured_media":1661,"comment_status":"close","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[],"class_list":["post-1659","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health"],"_links":{"self":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/1659","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1659"}],"version-history":[{"count":2,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/1659\/revisions"}],"predecessor-version":[{"id":1662,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/1659\/revisions\/1662"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/media\/1661"}],"wp:attachment":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1659"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1659"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1659"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}