FDA Publishes Merck's COVID-19 Oral Antiviral Treatment Presentation

The Maryland-based Center for Drug Evaluation and Research Antimicrobial Drugs Advisory Committee announced today the meeting briefing document was published for Merck's Molnupiravir, an oral antiviral treatment.

This U.S. FDA committee is scheduled to digital meet on November 30, 2021.

Led by Lindsey R. Baden, M.D., Chairperson, the committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules to treat mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.

According to the company, Molnupiravir inhibits the replication of the SARS-CoV-2 betacoronavirus, with similar activity across variants of concern.

Furthermore, it has a high barrier to resistance, with no evidence of resistance development to Molnupiravir in nonclinical or clinical studies to date.

Merck's proposed dosing regimen is 800 mg (administered as four 200 mg capsules) taken every 12 hours with or without food for five days.

And, the treatment should be started as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset.

Initially developed at Emory University, then by Ridgeback Biotherapeutics L.P., molnupiravir is classified as a mutagenic nucleotide analogue, the underlying biochemical mechanisms with the purified RdRp complex of SARS-CoV-2.

On November 4, 2021, the U.K. Medicines and Healthcare products Regulatory Agency granted authorization for molnupiravir, known locally as Lagevrio.