{"id":41444,"date":"2021-04-16T10:52:48","date_gmt":"2021-04-16T14:52:48","guid":{"rendered":"https:\/\/sciencebusiness.technewslit.com\/?p=41444"},"modified":"2021-04-16T10:52:48","modified_gmt":"2021-04-16T14:52:48","slug":"lilly-asks-fda-to-revoke-covid-19-therapy-clearance","status":"publish","type":"post","link":"https:\/\/technewslit.com\/sciencebusiness\/?p=41444","title":{"rendered":"Lilly Asks FDA to Revoke Covid-19 Therapy Clearance"},"content":{"rendered":"
\"SARS-CoV-2<\/a>
Scanning electron microscope image shows SARS-CoV-2 viruses emerging from the surface of cells cultured in the lab. (NIAID, NIH)<\/figcaption><\/figure>\n

16 Apr. 2021. Drug maker Eli Lilly and Co. asked the Food and Drug Administration to revoke its authorization for bamlanivimab alone to treat for Covid-19 infections. The pharmaceutical maker says its synthetic monoclonal antibody bamlanivimab<\/a> by itself does not neutralize emerging SARS-CoV-2 variants as well as bamlanivimab combined with etesevimab, another of its antibodies.<\/p>\n

Bamlanivimab was authorized by FDA as a treatment for infections from the original strain of SARS-CoV-2 causing mild to moderate symptoms. As reported by Science & Enterprise<\/a> in February, FDA also authorized bamlanivimab combined with etesevimab to treat non-hospitalized people with Covid-19 infections showing mild to moderate symptoms, but considered at high risk for severe symptoms of the disease.<\/p>\n

Lilly says bamlanivimab with etesevimab neutralizes more of the newer strains of the SARS-CoV-2 virus responsible for Covid-19 infections, including the B.1.427\/B.1.429 strain<\/a> that now accounts for half of the virus in California and is spreading to other states. The company developed the dual-antibody cocktail for the eventual emergence of viral mutations that resist one of the antibodies working alone.<\/p>\n

The company says it expected new variants to arise, and the request to revoke the authorization will encourage transition to the bamlanivimab\/etesevimab combination. “With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize,” says Lilly’s chief scientist Daniel Skovronsky<\/a> in a company statement<\/a>, “and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together.”<\/p>\n

Lilly is collaborating with fellow drug maker Amgen to manufacture bamlanivimab and etesevimab to meet global needs. The company says it plans to submit the dual-antibody cocktail to health authorities worldwide for regulatory review, and expects a full transition to the two-drug combination by June of this year.<\/p>\n

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