Merck's COVID-19 Oral Antiviral Molnupiravir Receives FDA Advisory Committee Support Despite Reduced Efficacy Data

On December 1, the FDA panel approved the EUA application for MSD's COVID-19 oral drug Molnupiravir. If authorized, patients with a confirmed diagnosis or virus exposure can use the drug at home with a doctor's prescription, without needing to receive treatment in a hospital or clinic as is required for monoclonal antibody drugs.

Molnupiravir, developed by MSD in collaboration with Ridgeback Biotherapeutics, has previously received emergency use authorization in the UK. However, the latest clinical data shows a significant drop in efficacy.

According to MSD's announcement last week, the final trial results showed that among the 699 participants in the placebo group, 68 were hospitalized or died, while among the 709 patients taking Molnupiravir, only 48 experienced disease progression. This corresponds to a reduction in the risk of hospitalization/death from 9.7% to 6.8%, with a relative risk reduction of 30%. Notably, there were 9 deaths in the placebo group and only 1 in the Molnupiravir group.

Nevertheless, the US FDA Advisory Committee voted 13 to 10 in favor of Merck Sharp & Dohme AG's antiviral drug molnupiravir, stating that the benefits of the drug outweigh the risks. The FDA is not obligated to follow the committee’s recommendation but typically chooses to do so.

In addition, Pfizer is also seeking FDA approval for its COVID-19 drug. The phase III clinical study of its oral COVID-19 medication Paxlovid showed that in mild to moderate COVID-19 patients who took the drug within three days of diagnosis, the risk of hospitalization or death was reduced by approximately 89%, comparable to the therapeutic effect of COVID-19 neutralizing antibodies.

Editor: Liuli

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