FDA Says Merck’s Anti-Covid Pill Works
The Food and Drug Administration said the experimental covid drug treatment was effective against the virus. Merck said it reduces hospitalization risks by 30%. But ongoing work is needed to determine its safety for use during pregnancy, including for risk of birth defects.
AP:
FDA: Merck COVID Pill Effective, Experts Will Review Safety
Federal health regulators say an experimental COVID-19 pill from Merck is effective against the virus, but they will seek input from outside experts on risks of birth defects and other potential problems during pregnancy. The Food and Drug Administration posted its analysis of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and effectiveness. The agency isn’t required to follow the group’s advice. (Perrone, 11/26)
Stat:
New Data, Analyses Take Some Of The Shine Off Merck’s Covid Pill
New data, in addition to analyses by scientists at the Food and Drug Administration, may take some of the shine off Merck’s experimental Covid-19 pill, molnupiravir. On Friday, the drug maker released full results from its study of the pill, molnupiravir, showing it reduced the risk of hospitalization by 30%, down from a decrease of 50% seen in an earlier analysis. In the 1,433-patient study, fewer patients died when they received the treatment. There were nine deaths in the placebo group in the final analysis, and one in the molnupiravir group. (Herper, 11/26)
Politico:
FDA Seeks Advice On Whether To Limit Covid-19 Pill In Pregnant People
The Food and Drug Administration will ask independent advisers Tuesday whether to limit the use of a Covid-19 antiviral pill in pregnant people due to potential risks, according to agency documents posted Friday. Merck and partner Ridgeback Biotherapeutics manufacture the drug, molnupiravir, which they say cuts in half the risk of hospitalization or death from Covid for patients with mild to moderate disease and has boosted hopes of finding a simple at-home treatment for the virus. Regulators are considering whether to authorize the pill's emergency use in adults who have been experiencing symptoms for less than five days and, if so, how to define who's considered high risk. (Gardner, 11/26)
