{"id":118593,"date":"2021-03-27T16:40:54","date_gmt":"2021-03-27T16:40:54","guid":{"rendered":"https:\/\/precoinnews.com\/?p=118593"},"modified":"2021-03-27T16:40:54","modified_gmt":"2021-03-27T16:40:54","slug":"glaxosmithkline-requests-emergency-authorization-from-fda-for-covid-antibody-drug","status":"publish","type":"post","link":"https:\/\/precoinnews.com\/business\/glaxosmithkline-requests-emergency-authorization-from-fda-for-covid-antibody-drug\/","title":{"rendered":"GlaxoSmithKline requests emergency authorization from FDA for Covid antibody drug"},"content":{"rendered":"<ul>\n<li>GlaxoSmithKline and Vir Biotechnology applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug.<\/li>\n<li>The companies are requesting clearance for use by high-risk people age 12 and older.<\/li>\n<\/ul>\n<p>In this article<\/p>\n<ul>\n<li><span>VIR<\/span><\/li>\n<li><span>GSK-GB<\/span><\/li>\n<\/ul>\n<p>GlaxoSmithKline and Vir Biotechnology on Friday applied for an emergency use authorization from the Food and Drug Administration for their monoclonal antibody drug.<\/p>\n<p>The companies are requesting clearance for use by high-risk people age 12 and older.<\/p>\n<p>The FDA submission is based on an interim analysis of a phase three trial that evaluated the drug for the early treatment of Covid-19 in adults at high risk of hospitalization. The drug reduced hospitalizations or death from Covid by 85% compared with a placebo. The trial results were based on 583 patients.<\/p>\n<p>&quot;As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrolment due to evidence of profound efficacy,&quot; the companies said in a statement.<\/p>\n<p>The companies started testing the antibody on early-stage Covid patients in August, hoping to keep symptoms from progressing. Antibody drugs gained attention after they were used to treat former President Donald Trump last year.<\/p>\n<p>U.S. health officials say antibody drugs already authorized for use \u2013 from Regeneron and Eli Lilly \u2013 are being underutilized.<\/p>\n<p>GSK said the companies will also continue discussions with the European Medicines Agency and other global regulators to make the drug available to Covid patients as soon as possible.<\/p>\n<p><em>-Reuters contributed to this report.<\/em><\/p>\n<p>Source: <a href=\"https:\/\/www.cnbc.com\/2021\/03\/26\/covid-glaxosmithkline-requests-emergency-authorization-from-fda-for-antibody-drug.html\" target=\"_blank\" rel=\"noopener\">Read Full Article<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>GlaxoSmithKline and Vir Biotechnology applied for an<\/p>\n","protected":false},"author":3,"featured_media":118592,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[23051],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - 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