Merck’s Molnupiravir Sheds Efficacy Points Ahead of Key FDA Meeting

, , , , , ,

Merck’s Molnupiravir Sheds Efficacy Points Ahead of Key FDA Meeting

The latest data from Merck and Ridgeback Biotherapeutics’ MOVe-OUT trial on the use of molnupiravir to treat COVID-19 in adults has shown a lower efficacy than previously reported.

Updated results demonstrate a relative risk reduction of 30% in non-hospitalized adult patients with mild-to-moderate symptoms of COVID-19. This is a notable drop from the 50% recorded in October under the Phase III MOVe-OUT trial, which represented only 775 participants from the total target number.

The most recent data now shows results from all 1,433 participants, demonstrating a reduced risk of hospitalization or death from 9.7% in those who were given a placebo to 6.8% among those who were given molnupiravir. Adverse events were consistent with the profile posted in October, with nine deaths logged from the placebo group and only one from the molnupiravir group.

Despite the lower risk reduction rate, researchers are still optimistic about the overall favorable risk assessment for the drug, especially in adults who are at high risk for disease progression. Merck has already submitted its results to the U.S. Food and Drug Administration (FDA) for review, and the same will be presented to the Antimicrobial Drugs Advisory Committee on November 30.

The MOVe-OUT trial was conducted worldwide in over 170 sites in countries including Argentina, Brazil, China, Germany, Israel, Italy, Mexico, Philippines, Poland, Russia, Japan, South Africa, Taiwan, Spain, the U.K. and the U.S.

Chris Hondros/Getty Images

The FDA is currently reviewing molnupiravir for emergency use authorization. The drug has already been approved for use in the U.K., while the European Medicines Agency (EMA) has placed it under review for marketing authorization.

“[We] have conducted a rigorous development program for molnupiravir, and believe that it has the potential to address a significant unmet medical need for an oral medicine for adults with COVID-19 who are at risk for progressing to severe COVID-19 and/or hospitalization. We look forward to working with the FDA and other agencies as they review our applications,” Merck and Ridgeback Biotherapeutics said in a joint statement.

Molnupiravir is an orally administered type of ribonucleoside analog that can stop SARS-CoV-2, the cause of COVID-19, from replicating. It is currently being studied as a single drug, and no drug interactions have been observed while using it so far.

Pending approvals, its developers expect to produce 10 million courses of treatment by the end of the year, with more to be released in 2022. In early 2021, Merck signed a procurement agreement with the U.S. Government, which will have the company supply some 1.7 million courses of the drug. Merck is also in talks with other governments worldwide for their respective supplies.

BioSpace source: