Merck (NYS:MRK) and partner Ridgeback Biotherapeutics said Monday the European Medicines Agency has started a rolling review of molnupiravir, its oral antiviral treatment for COVID-19 in adults. "Merck plans to work with the EMA's Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application," the company said in a statement. The partner have already submitted an application for emergency use authorization for the treatment with the U.S. Food and Drug Administration and has said it would seek the same from other regulatory agencies around the world. If molnupiravir is granted marketing authorization in the EU, it would become the first oral medicine for the coronavirus-borne illness in the trading bloc. Merck and Ridgeback already disclosed data from a Phase 3 trial of molnupiravir that showed it reduced the risk of hospitalization or death in adults at risk from severe COVID-19 by 50%. While several effective vaccines have been developed against the illness, far fewer treatments have emerged, and those that have require infusions and must be administered in a clinical setting. Molnupiravir is a pill administered orally in capsule form every 12 hours for five days, according to clinicaltrials.gov. Through Day 29 in the Phase 3 trial, no patients given molnupiravir died, compared with the eight patients who died on the placebo. Merck expects to produce 10 million courses of the treatment by the end of the year. Merck shares were slightly higher premarket and have gained 4% in the year to date, while the Dow Jones Industrial Average (DOW:DJIA) has gained 17%.
Oct. 25, 2021, 6:16 a.m. EDT
