UK Authorizes Merck, Ridgeback’s Oral COVID Antiviral Molnupiravir

Merck and Ridgeback Biotherapeutics received authorization in the UK for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 test and who have at least one risk factor for developing severe illness.
In the UK, LAGEVRIO (lah-GEV-ree-oh) is the planned trademark for molnupiravir. Merck’s application with the U.S. FDA for Emergency Use Authorization of molnupiravir is under review and recently the European Medicines Agency initiated a rolling review of the company’s Marketing Authorization Application.
“The first global authorization of molnupiravir is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges. In pursuit of Merck’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” said Robert M. Davis, chief executive officer and president, Merck.
“As an oral therapeutic, molnupiravir offers an important addition to the vaccines and medicines deployed so far to counter the COVID-19 pandemic,” said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories. “We are very grateful to the investigators, patients and their families for their critical contributions to the MOVe-OUT study that made this authorization possible.”
The authorization is based on positive results from interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized, unvaccinated adult patients with lab-confirmed mild-to-moderate COVID-19, symptom onset within five days of study randomization and at least one risk factor associated with poor disease outcomes (e.g., heart disease, diabetes).
At the previously announced interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo.
Merck has been producing molnupiravir at risk. Merck expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
Earlier this year, Merck entered into an agreement with the U.S. Government to supply approximately 1.7 million courses of molnupiravir, upon EUA or approval from the FDA.