FDA's Plans for Molnupiravir COVID Pill Explained As U.K First Country To Approve Drug

Regulators in the U.K. became the first public health body to approve the use of experimental COVID antiviral drug molnupiravir on Thursday.

The U.K.'s Medicines and Healthcare Products Regulatory Agency's (MHRA) authorization of the drug, which is produced by the U.S.-based pharmaceutical giant Merck, marks the first time any oral antiviral has been approved for the treatment of adults with COVID-19.

"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," Merck's CEO and president Robert M. Davis said in a statement to the press. "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."

The oral treatment, which was developed with Ridgeback Biotherapeutics and began human testing in April 2020, has been approved for use in the treatment of mild-to-moderate COVID cases in adults who have a risk factor that indicates they could develop severe illness.

Molnupiravir is currently under review by several other regulatory authorities, including the European Medicines Agency and the United States Food and Drug Administration (FDA).

Merch announced that it had submitted an emergency use authorization application to FDA for molnupiravir on October 11. The application was submitted with 10 days of positive results from the Phase 3 MOVe-OUT clinical trial, which indicated that molnupiravir reduced the risk of hospitalization or death by approximately 50 percent.

On October 14, following the application, the FDA announced that its Antimicrobial Drugs Advisory Committee (AMDAC) would meet on November 30 to consider authorizing the use of molnupiravir. The FDA said this was the soonest possible meeting that could be organized to discuss the molnupiravir application.

Before the meeting, which will be streamed live via the agency's YouTube page, the FDA said it will thoroughly evaluate the data and information submitted. Such meetings are not always arranged for emergency application, but the FDA felt it necessary in the case of molnupiravir.

"The FDA is evaluating the safety and effectiveness data submitted by Merck and Ridgeback in their emergency use authorization request for molnupiravir, a new oral treatment for high-risk individuals with a newly diagnosed COVID-19 infection," the director of the FDA's Center for Drug Evaluation and Research, Patrizia Cavazzoni, said in October.

"We believe that, in this instance, a public discussion of these data with the agency's advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating to make a decision about whether to authorize this treatment for emergency use," Cavazzoni added.

That means that as yet there is so set-date at which molnupiravir could be approved in the U.S. if the FDA approves it at all.

Authorization by MHRA in the U.K. is based on positive results delivered by the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized, unvaccinated adult patients with laboratory-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.

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

COVID-19 experimental antiviral drug MOLNUPIRAVIR
A stock image of COVID-19 experimental antiviral drug MOLNUPIRAVIR. The U.K. has become the first country to approve the antiviral's use in COVID treatment. Plyushkin/Getty