Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics have won emergency use authorization from FDA for the investigational oral antiviral molnupiravir (MK-4482, EIDD-2801).
In late November, an FDA advisory panel narrowly voted in favor of authorizing molnupiravir.
FDA recently also granted emergency use authorization to Pfizer’s (NYSE:PFE) oral SARS-CoV-2 antiviral Paxlovid (nirmatrelvir and ritonavir).
FDA’s authorization of molnupiravir covers its use to treat mild-to-moderate COVID-19 in individuals at least 18 “who are at high-risk for progression to severe COVID-19.” The authorization constrains the use of the drug to individuals who cannot feasibly use other authorized COVID-19 treatments. FDA does not recommend the medication for patients who are hospitalized with COVID-19.
The authorization does not support the use of molnupiravir as pre-exposure or post-exposure prophylaxis for COVID-19.