The FDA has revised the Emergency Use Authorization (EUA) for Merck & Co Inc's (NYSE:MRK) COVID-19 pill molnupiravir, explaining that it should be used only if other treatments are not available or clinically appropriate.
- Regulators also said other more highly efficacious infused drugs, including Gilead Sciences Inc's (NASDAQ:GILD) remdesivir, should be used before molnupiravir.
- The EUA for molnupiravir, initially issued in December, said the pill should be for mild-to-moderate COVID-19 in adults with positive results of SARS-CoV-2 viral testing and who are at high risk for progressing to hospitalization or death, but only when alternative treatment options authorized by FDA are not accessible or clinically appropriate.
- In January, the FDA approved the expanded use of remdesivir for the non-hospitalized treatment of adults and pediatric patients. Now, FDA says this treatment should take precedence over molnupiravir, too.
- The update FDA follows questions around the cause of the drop-off in the pill's ability to prevent hospitalizations and deaths, which went from 50% to 30% between interim and final trial results.
- Meanwhile, the European Medicines Agency has yet to sign off on the Merck pill, and according to the Financial Times, it's not clear that it will. The EMA's human drugs committee is set to discuss molnupiravir next week.
- Meanwhile, pharmacies have already begun to complain about an overabundance of Merck pills in the US. Merck expects to pull $5 billion - $6 billion for the medicine in 2022.
- Price Action: MRK shares are down 0.42% at $76.04 during the market session on the last check Friday.
