FDA approves Molnupiravir as COVID-19 treatment pill
by Pinedale Online!
December 23, 2021
On Thursday, Dec. 23, 2021, the U.S. Food and Drug Administration authorized an antiviral drug called Molnupiravir to treat COVID-19. The drug is authorized for emergency use. The oral pill drug is cleared for use in adults with mild to moderate COVID-19 who are at risk for severe disease.
Molnupiravir is sold under the brand name Lagevrio among others. It is an antiviral medication that inhibits the replication of certain RNA viruses. Molnupiravir is a prodrug that exerts its antiviral action through introduction of copying errors during viral RNA replication. The drug was developed by Ridgeback Biotherapeutics in partnership with Merck & Co.
In November, 2021, an FDA advisory committee voted narrowly in favor of recommending the treatment. The close vote reflected concerns committee members had about both the effectiveness and the safety of the drug, including the potential risk of mutations in the virus and to the DNA in human cells, especially in pregnant women and their fetuses.
Related Links
Coronavirus (COVID-19) Update: FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults - fda.gov, December 23, 2021
U.S. Food and Drug Administration Center for Drug Evaluation and Research FDA Briefing Document Antimicrobial Drugs Advisory Committee Meeting November 30, 2021 - fda.gov, November 30, 2021
Molnupiravir: long-term safety questions linger as approvals approach - By Darcy Jimenez, pharmaceutical-technology.com, November 3, 2021
Molnupiravir: coding for catastrophe - nature.com, September 13, 2021
Molnupiravir Mutations - By Derek Lowe, science.org, October 13, 2021
Molnupiravir - Wikipedia
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