Merck makes beeline to FDA, seeking approval for COVID-19 antiviral 10 days after reporting data

Merck isn’t hanging around. Ten days after reporting data on its oral COVID-19 antiviral molnupiravir, Merck has filed for emergency use authorization from the FDA as part of a rapid global push to get the drug to patients.

Oct. 1, Merck and its partner Ridgeback Biotherapeutics reported that molnupiravir halved the risk of hospitalization and death in a phase 3 clinical trial. No patients died in the molnupiravir arm, compared to eight deaths in the placebo group. With the U.S. averaging 1,600 to 2,000 deaths a day in recent weeks, the results suggest molnupiravir can have a significant impact, driving Merck to act fast.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck CEO Robert Davis said in a statement. 

Merck’s filing confirms its status as the front-runner in the race to bring an oral COVID-19 treatment to market. Although an antiviral, Gilead’s remdesivir, and anti-SARS-CoV-2 antibodies are available, their use in the earliest stages of infection is limited by the need to infuse or inject the molecules. Merck is at the head of a wave of drug developers aiming to enable early, effective interventions.

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Roche, in partnership with Atea Pharmaceuticals, is running a phase 3 clinical trial of the oral antiviral RO7496998 in patients with mild to moderate COVID-19. puts the completion date in November. Pfizer is set to deliver data around the same time, with studies in low- and high-risk patients scheduled to hit their primary completion dates in October and November, respectively. The conclusion of Appili Therapeutics’ phase 3 favipiravir trial is also imminent.

The upcoming data drops could create significant competition, with the 50% fall in hospitalizations and deaths linked to molnupiravir leaving ample scope for improvement, but, for now, Merck has a clear run at a potentially significant market and a chance to change the course of the pandemic. 

Questions still remain. Merck has yet to present detailed safety data on molnupiravir, a drug with a novel mechanism of action that drives viral mutations, and it remains to be seen how regulators and payers will determine who is eligible for the antiviral. Like several other developers of oral antivirals, Merck excluded vaccinated people from its phase 3 study.