{"id":16563,"date":"2020-10-27T10:05:36","date_gmt":"2020-10-27T14:05:36","guid":{"rendered":"https:\/\/www.singlecare.com\/blog\/?p=16563"},"modified":"2020-10-27T10:05:36","modified_gmt":"2020-10-27T14:05:36","slug":"veklury-remdesivir-coronavirus-fda-approval","status":"publish","type":"post","link":"https:\/\/www.singlecare.com\/blog\/news\/veklury-remdesivir-coronavirus-fda-approval\/","title":{"rendered":"FDA approves first COVID-19 treatment"},"content":{"rendered":"<p><i><span style=\"font-weight: 400;\">CORONAVIRUS UPDATE: As experts learn more about the novel coronavirus, news and information changes. For the latest on the COVID-19 pandemic, please visit the<\/span><\/i><a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/index.html\"> <i><span style=\"font-weight: 400;\">Centers for Disease Control and Prevention<\/span><\/i><\/a><i><span style=\"font-weight: 400;\">.<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">The U.S. Food and Drug Administration (FDA) approved the first targeted COVID-19 treatment, <\/span><span style=\"font-weight: 400;\">Veklury (remdesivir), on Oct. 22. The drug from Gilead Sciences, Inc. can now be used for anyone ages 12 and older who weigh at least 40 kilograms (roughly 88 pounds) and is hospitalized with the novel coronavirus.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Remdesivir coronavirus results\u00a0<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">The approval was based on the FDA\u2019s analysis of three randomized,<\/span> <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2020\/214787Orig1s000Sumr.pdf\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">controlled clinical experiments<\/span><\/a><span style=\"font-weight: 400;\"> of hospitalized adult patients with mild to severe COVID-19. The studies found that treatment with the drug produced clinical improvements across several outcomes, including a faster time to recovery and reduced disease progression, as well as a trend toward reduced mortality, in comparison to placebo.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cThe FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency,\u201d said FDA Commissioner Stephen M. Hahn, MD in <\/span><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-first-treatment-covid-19\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">a statement<\/span><\/a><span style=\"font-weight: 400;\">. \u201c[This] approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic.\u201d<\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The antiviral treatment was given emergency use authorization in May, and can still be used in that capacity for patients younger than 12 years old and weighing at least 3.5 kilograms (roughly 8 pounds). Clinical trials on the safety and efficacy of the drug in children younger than 12 are still ongoing.<\/span><\/p>\n<p><b>RELATED: <\/b><a href=\"https:\/\/www.singlecare.com\/blog\/news\/coronavirus-symptoms-and-incubation-period\/\"><b>How to tell if your coronavirus symptoms are mild, moderate, or severe<\/b><\/a><\/p>\n<h2><span style=\"font-weight: 400;\">What is Veklury and how does it work?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Veklury is an antiviral treatment delivered intravenously as an infusion and works by limiting how well SARS-CoV-2, the virus that causes COVID-19, can make copies of itself. The drug isn\u2019t a vaccine or a cure. It\u2019s intended to help people with COVID-19 recover more quickly.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Before receiving Veklury, patients will undergo certain blood tests to evaluate their liver and kidney function to make sure they can safely be treated with the drug. This organ function will also be monitored throughout the treatment course. That\u2019s partly because one of the potential side effects of Veklury is increased liver enzymes, a potential sign of liver injury. Other possible side effects include hypersensitivity reactions presenting as low blood oxygen level, fever, wheezing, swelling, shortness of breath, sweating or shivering, according to the FDA.\u00a0<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">How much does Veklury cost?<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Gilead currently charges<\/span> <a href=\"https:\/\/www.gilead.com\/news-and-press\/press-room\/press-releases\/2020\/6\/an-open-letter-from-daniel-oday-chairman--ceo-gilead-sciences\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: 400;\">$2,340<\/span><\/a> <span style=\"font-weight: 400;\">for a five-day treatment for people with government-based health insurance and $3,120 for people with private health insurance. It\u2019s available to hospitals and healthcare facilities that treat COVID-19 patients.<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>CORONAVIRUS UPDATE: As experts learn more about the novel coronavirus, news and information changes. For the latest on the COVID-19 pandemic, please visit the Centers for Disease Control and Prevention. The U.S. Food and Drug Administration (FDA) approved the first targeted COVID-19 treatment, Veklury (remdesivir), on Oct. 22. The drug from Gilead Sciences, Inc. can [&hellip;]<\/p>\n","protected":false},"author":85,"featured_media":6926,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[4589,4114],"tags":[14636,72,4141],"coauthors":[10392],"class_list":["post-16563","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-info","category-news","tag-coronavirus","tag-fda","tag-fda-approvals","wpautop"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.4 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Veklury (remdesivir): FDA approved to treat COVID-19<\/title>\n<meta name=\"description\" content=\"The FDA-approved Veklury (remdesivir) as the first treatment for hospitalized COVID-19 patients. 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