Advisers to the Food and Drug Administration have endorsed the authorization of an oral antiviral pill for treating COVID-19 in high-risk patients.
Molnupiravir, developed by Ridgeback Biotherapeutics and Merck, is in line for emergency use authorization by the FDA. The Tuesday vote recommending it be prescribed to U.S. adults was a close one, at 13 to 10, news outlets reported.
Members of the Antimicrobial Drugs Advisory Committee had concerns about the drug’s safety, especially regarding potential risks posed to pregnant women and fetuses. There also were questions about its efficacy. The most recent analysis of clinical trial data showed that molnupiravir reduced the odds of serious illness and hospitalization by 30% in patients with COVID-19 — significantly lower than the 50% reduction shown previously.
But after reviewing the data, some panelists concluded that potential benefits to certain high-risk patients and the need for more accessible COVID-19 treatments during the pandemic emergency outweighed potential risks.
Door open for endorsement to be revoked
Notably, panelists on both sides of the vote agreed that if an oral drug option with a better safety and efficacy profile comes along, the molnupiravir endorsement should be revoked, according to FiercePharma. In the meantime, Merck’s pill must receive further OKs from the FDA and the Centers for Disease Control and Prevention to be authorized for use.
One other experimental antiviral pill also is under consideration for an EUA. Pfizer’s drug Paxlovid reduced the rate of hospitalization and death from COVID-19 by nearly 90% in clinical trials.
An easily administered, relatively inexpensive pill could be a pandemic game-changer for patients and healthcare providers, observers contend. The only other COVID-19 treatments currently available are monoclonal antibodies and the antiviral drug remdesivir (Veklury). These drugs are very effective but must be delivered either via intravenous infusion, or as in the case of the antibody drug REGEN-COV, in a series of shots.
Geared for high-risk patients
Molnupiravir is intended to treat mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test who are at high risk for progression to severe illness including hospitalization or death, according to Merck. In clinical trials, it was given to study participants twice a day for five days, within five days after COVID-19 symptoms were detected.
Monoclonal antibodies, currently a standard of COVID-19 care in many long-term care facilities, also are effective within a short window of time after patients receive a positive COVID-19 test result.