Merck (NYSE: MRK) and its partner Ridgeback Biotherapeutics has announced that the European Medicines Agency (EMA) has begun a rolling review for molnupiravir, the experimental antiviral that could be the first oral treatment for COVID-19 to hit the market.
Merck has also submitted emergency use authorization (EUA) paperwork related to the drug to FDA.
The company is also pursuing marketing authorization in other countries across the globe.
“This application to the EMA is another step in our efforts to bring molnupiravir forward to patients globally,” said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories, in a statement.
Interim data from the Phase 3 MOVe-OUT clinical trial found that the drug effectively reduced symptom progression in non-hospitalized patients with mild-to-moderate COVID-19. The patients in that study were deemed to have an elevated risk of developing severe COVID-19 or hospitalization.
Overall, the drug appeared to reduce the risk of hospitalization or death by roughly 50%.
The drug also appeared to be well tolerated, with side effects roughly even between drug and placebo groups.
Filed Under: Infectious Disease