Molnupiravir by Merck May Be Approved for Emergency Use by FDA

U.S. pharmaceutical company Merck announced on Monday that it has applied to the Food and Drug Administration (FDA) for approval of its antiviral coronavirus tablet molnupiravir, The Hill reports.

The emergency use permission was sought to treat mild-to-moderate coronavirus symptoms in individuals who are at risk of escalating to severe symptoms of COVID-19 and/or hospitalization, according to a press release by Merck.

The pharmaceutical corporation said earlier in October that tests had revealed that molnupiravir, a five-day therapy developed in collaboration with Ridgeback Biotherapeutics, decreased the chance of hospitalization by 50%.

According to Robert M. Davis, Merck’s chief executive officer and president, who made a statement released on Monday, the unprecedented scope of the pandemic necessitates unprecedented speed, which medical staff have demonstrated by submitting the request for molnupiravir to the FDA within 10 days of getting the data back.

Merck claims that their tablet, which inhibits the enzyme that causes coronavirus to replicate itself, is likely effective against all coronavirus strains, including the highly contagious delta version.

If the FDA grants emergency use approval, the U.S. government already has a distribution arrangement with Merck to buy roughly 1.7 million doses of molnupiravir.

Singapore, South Korea, Thailand, and Australia have already agreed to buy the tablets from Merck.

Molnupiravir has been described as a “game-changer” by former FDA Commissioner Scott Gottlieb. Last week, he projected that the “pandemic phase” of coronavirus will be over once the antiviral tablets and coronavirus vaccinations are officially approved and allowed for use of children under the age of 12.

Nonetheless, Gottlieb stated that 1.7 million units of medication would be insufficient and that rationing would be necessary.

President Biden’s top medical advisor, Anthony Fauci, stated earlier in October that it is a “false narrative” to believe that coronavirus vaccinations will be unnecessary if Merck’s antiviral pill therapy is authorized by the FDA.