{"id":79197,"date":"2022-02-12T23:54:55","date_gmt":"2022-02-12T18:24:55","guid":{"rendered":"https:\/\/centralrecorder.com\/f-d-a-clears-monoclonal-antibody-drug-from-eli-lilly\/"},"modified":"2022-02-12T23:54:55","modified_gmt":"2022-02-12T18:24:55","slug":"f-d-a-clears-monoclonal-antibody-drug-from-eli-lilly","status":"publish","type":"post","link":"https:\/\/centralrecorder.com\/f-d-a-clears-monoclonal-antibody-drug-from-eli-lilly\/","title":{"rendered":"F.D.A. Clears Monoclonal Antibody Drug From Eli Lilly"},"content":{"rendered":"<div>\n<div class=\"css-53u6y8\">\n<p class=\"css-axufdj evys1bk0\">With Covid treatments still in short supply in the United States, the Food and Drug Administration on Friday <a class=\"css-1g7m0tk\" href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/coronavirus-covid-19-update-fda-authorizes-new-monoclonal-antibody-treatment-covid-19-retains\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">gave emergency authorization to a new monoclonal antibody drug<\/a> that has been found in the laboratory to be potent against the Omicron variant of the coronavirus.<\/p>\n<p class=\"css-axufdj evys1bk0\">The Biden administration said it would make the therapy immediately available to states free of charge.<\/p>\n<p class=\"css-axufdj evys1bk0\">The authorization of the treatment, bebtelovimab, means that the United States now has four drugs available for high-risk Covid patients early in the course of their illness that have been found to neutralize the Omicron variant. While there is a greater menu of Covid pills and treatments now than at any other point in the pandemic, the drugs have been so scarce that doctors have been forced to make painful rationing decisions during the Omicron surge.<\/p>\n<p class=\"css-axufdj evys1bk0\">The drug that the F.D.A. authorized on Friday is manufactured by Eli Lilly, which <a class=\"css-1g7m0tk\" href=\"https:\/\/investor.lilly.com\/news-releases\/news-release-details\/lilly-will-supply-600000-doses-bebtelovimab-us-government\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">said on Thursday<\/a> that it had signed a contract with the Department of Health and Human Services to provide the government with up to 600,000 courses of the treatment for at least $720 million. The company said it had already manufactured hundreds of thousands of doses and was ready to begin shipments within 24 hours.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div>\n<div class=\"css-53u6y8\">\n<p class=\"css-axufdj evys1bk0\">The Lilly drug has not been tested in a study that can show whether it can stave off severe disease. The F.D.A. said it should not be a preferred product and instead should be used only when alternative treatments are not \u201caccessible or clinically appropriate.\u201d Federal health officials have given a similar designation to a Covid pill from Merck and the Covid vaccine from Johnson &amp; Johnson.<\/p>\n<p class=\"css-axufdj evys1bk0\">However, there are data suggesting Eli Lilly\u2019s drug is safe and may reduce the amount of virus that builds up in people who are sick with Covid.<\/p>\n<p class=\"css-axufdj evys1bk0\">Like other drugs for recently diagnosed Covid patients, Lilly\u2019s new treatment is authorized for people who are vulnerable to becoming seriously ill because they are older or have a medical condition like obesity or diabetes. People as young as 12 can be eligible.<\/p>\n<p class=\"css-axufdj evys1bk0\">The drug is meant to be given as a quick intravenous injection by a health care provider, typically at a clinic or hospital. It must be administered within seven days of symptoms starting.<\/p>\n<p class=\"css-axufdj evys1bk0\">Eli Lilly tested the drug in a <a class=\"css-1g7m0tk\" href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04634409?term=LY-CoV1404&amp;draw=2&amp;rank=1\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">mid-stage clinical trial<\/a> before the emergence of the highly transmissible Omicron variant; the trial enrolled Delta-infected patients. Unvaccinated volunteers with an average risk of becoming seriously ill with Covid had their symptoms clear up faster when they were treated with the drug and had a lower level of virus in their bodies after five days compared with those who received a placebo, the F.D.A. said.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div>\n<div class=\"css-53u6y8\">\n<p class=\"css-axufdj evys1bk0\">The study also enrolled higher-risk people, some of whom were vaccinated, and examined whether the drug was safe for them. Across the company\u2019s safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash.<\/p>\n<div role=\"complementary\" aria-labelledby=\"storyline-latest-updates\" class=\"css-y1f5ai\">\n<div class=\"css-8atqhb\">\n<div class=\"css-rchdvv\"><time class=\"css-101kej7\" datetime=\"2022-02-12T17:24:09.580Z\"><span>Updated\u00a0<\/span><\/p>\n<p><span class=\"css-1stvlmo\">Feb. 12, 2022, 12:24 p.m. ET<\/span><span class=\"css-kpxlkr\"\/><\/p>\n<p><\/time><span class=\"css-1dv1kvn\" aria-live=\"polite\"\/><\/div>\n<\/div>\n<\/div>\n<p class=\"css-axufdj evys1bk0\"><a class=\"css-1g7m0tk\" href=\"https:\/\/combatcovid.hhs.gov\/possible-treatment-options-covid-19\/monoclonal-antibodies-high-risk-covid-19-positive-patients\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">Monoclonal antibody drugs<\/a> are synthetic versions of the antibodies generated naturally when the body fights off the virus. They were widely used during the Delta surge last summer, particularly in red states. But during the ongoing surge, the country\u2019s supply of the drugs has been sharply reduced because two of the three authorized products are ineffective against Omicron.<\/p>\n<p class=\"css-axufdj evys1bk0\">That left just one such treatment, made by GlaxoSmithKline, available. Biden administration officials <a class=\"css-1g7m0tk\" href=\"https:\/\/www.phe.gov\/emergency\/events\/COVID19\/therapeutics\/distribution\/Pages\/data-tables.aspx\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">have been shipping<\/a> roughly 50,000 doses a week of the Glaxo treatment to states. The purchase of bebtelovimab will allow them to double the number of people receiving monoclonal antibodies that work against Omicron.<\/p>\n<p class=\"css-axufdj evys1bk0\">Falling case counts and a gradual increase in the supply of two new treatments meant for the same group of high-risk patients \u2014 antiviral pills from Pfizer and Merck \u2014 are also helping ease treatment shortages.<\/p>\n<section role=\"complementary\" class=\"css-14gh6yt\" aria-label=\"The Coronavirus Pandemic: Key Things to Know\">\n<h2 class=\"css-ba3d02\">The Coronavirus Pandemic: Key Things to Know<\/h2>\n<hr\/>\n<div id=\"storyline-context-container\" aria-live=\"polite\" aria-atomic=\"true\"><span class=\"css-1ly73wi e1tej78p0\">Card 1 of 4<\/span><\/p>\n<div data-scrolled-index=\"0\" class=\"swiper css-1goft0b\">\n<div class=\"css-1vt1os1\" aria-hidden=\"false\">\n<div class=\"css-1f5t7xj\" data-testid=\"context-card\">\n<p class=\"itemClass\"><strong>Covid boosters.<!-- --> <\/strong><span>Data released by the Centers for Disease Control and Prevention showed that booster shots against the coronavirus lose much of their potency after about four months, adding to evidence suggesting that some Americans may need a fourth dose.<\/span><\/p>\n<\/div>\n<\/div>\n<div class=\"css-1vt1os1\" aria-hidden=\"true\">\n<div class=\"css-1f5t7xj\" data-testid=\"context-card\">\n<p class=\"itemClass\"><strong>Vaccines for young children.<!-- --> <\/strong><span>The Food and Drug Administration said that it would wait for data\u00a0on the effectiveness of three doses of the Pfizer-BioNTech coronavirus vaccine in children younger than 5 before deciding whether to authorize the vaccine for that age group.<\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<p class=\"css-axufdj evys1bk0\">Xavier Becerra, the secretary of health and human services, announced the deal with Lilly on Thursday. He said the company would ship the government 300,000 courses in February and another 300,000 in March. The contract includes a future option for 500,000 additional doses.<\/p>\n<p class=\"css-axufdj evys1bk0\">Before the emergence of Omicron, the country\u2019s three authorized antibody treatments \u2014 from Eli Lilly, Regeneron and Glaxo \u2014 were found in clinical trials to sharply reduce the risk of being hospitalized or dying from the virus.<\/p>\n<p class=\"css-axufdj evys1bk0\">But when Omicron was discovered, laboratory studies quickly found that the products from Eli Lilly and Regeneron were not effective against Omicron. Last month, the F.D.A. sharply limited use of the two products, and the federal government <a class=\"css-1g7m0tk\" href=\"https:\/\/www.phe.gov\/emergency\/events\/COVID19\/therapeutics\/distribution\/Pages\/data-tables.aspx\" title=\"\" rel=\"noopener noreferrer\" target=\"_blank\">stopped shipping them<\/a> to states.<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n<div>\n<div class=\"css-53u6y8\">\n<p class=\"css-axufdj evys1bk0\">Eli Lilly had been developing bebtelovimab long before the emergence of Omicron as part of its collaboration with the Vaccine Research Center, an arm of the National Institute of Allergy and Infectious Diseases. It did so out of \u201cfear that there could be a new highly resistant variant,\u201d Dr. Daniel Skovronsky, Eli Lilly\u2019s chief scientific officer, said in an interview.<\/p>\n<p class=\"css-axufdj evys1bk0\">The company began safety testing of bebtelovimab early last year and then manufactured hundreds of thousands of doses of the drug before knowing whether it would be needed. More recently, the company tested the drug in laboratory experiments that found that it remained highly potent against Omicron.<\/p>\n<p class=\"css-axufdj evys1bk0\">Dr. Skovronsky said the urgency of the fast-changing pandemic and strong laboratory data justified bringing the drug to market before testing it in patients with Omicron.<\/p>\n<p class=\"css-axufdj evys1bk0\">\u201cIf the national strategy is every time there\u2019s a new variant, we need to do clinical trials for that variant, we\u2019ll never have the drugs in time,\u201d he said. \u201cWe\u2019ll always be one variant behind.\u201d<\/p>\n<\/div>\n<aside class=\"css-ew4tgv\" aria-label=\"companion column\"\/><\/div>\n","protected":false},"excerpt":{"rendered":"<p>With Covid treatments still in short supply in the United States, the Food and Drug Administration on Friday gave emergency authorization to a new monoclonal antibody drug that has been found in the laboratory to be potent against the Omicron variant of the coronavirus. The Biden administration said it would make the therapy immediately available [&hellip;]<\/p>\n","protected":false},"author":51,"featured_media":79198,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10,3266],"tags":[],"jetpack_featured_media_url":"https:\/\/centralrecorder.com\/wp-content\/uploads\/2022\/02\/FDA-Clears-Monoclonal-Antibody-Drug-From-Eli-Lilly.jpg","_links":{"self":[{"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/posts\/79197"}],"collection":[{"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/users\/51"}],"replies":[{"embeddable":true,"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/comments?post=79197"}],"version-history":[{"count":0,"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/posts\/79197\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/media\/79198"}],"wp:attachment":[{"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/media?parent=79197"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/categories?post=79197"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/centralrecorder.com\/wp-json\/wp\/v2\/tags?post=79197"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}