UK first to approve Merck’s COVID-19 pill

Company VP says it is an ‘important addition’ to vaccines

Britain’s regulator became the first in the world to approve Merck & Co.’s COVID-19 antiviral pill, describing the treatment as safe and effective after a swift review.

The drug, molnupiravir, was authorized for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency said Thursday.

Merck shares rose 2% in premarket trading in the United States.

Boris Johnson’s government plans to focus on antiviral treatments, while rolling out boosters to bolster immunity as winter approaches. The approval extends the U.K.’s record of quick action on COVID-19 clearances after it was the first western nation to give the go-ahead to Pfizer Inc. and BioNTech SE’s vaccine last year.

The U.K. has already announced deals to secure two new COVID-19 treatments: 480,000 courses of Merck’s pill and 250,000 courses of another antiviral made by Pfizer. Based on clinical trial data, Merck’s treatment is most effective when taken during early stages of infection, the regulator said.

COVID-19 infections in England reached their highest level yet in October, based on a study published Thursday. While hospitalizations and deaths were low, the React-1 study led by Imperial College London recorded the highest prevalence of cases since research began May 2020. COVID-19 infections among study participants increased to 1.72%, or 1 in 58 people, more than double the level in the previous month’s report.

Merck and its partner, Ridgeback Biotherapeutics LP, sought emergency use authorization in the U.S. for molnupiravir last month.

The U.S. Food and Drug Administration has scheduled an advisory committee hearing for Nov. 30, saying it would weigh data on use of the drug to treat mild to moderate cases in high-risk adults.

The European Medicines Agency has begun a rolling review of the company’s application for marketing authorization in the European Union.

“As an oral therapeutic, molnupiravir offers an important addition to vaccines and medicines deployed so far to counter the COVID-19 pandemic,” Dr. Dean Y. Li, executive vice president and president of Merck Research Laboratories, said in a statement Thursday.