NJ-Based Drugmaker Merck Asks FDA To Authorize Anti-COVID-19 Pill

CLARK, NJ — The New Jersey-based pharmaceutical company Merck announced Monday that it is seeking U.S. Food and Drug Administration emergency use authorization for its experimental antiviral COVID-19 treatment, molnupiravir.

If cleared by the FDA, it would become the first oral antiviral medicine for the treatment of COVID-19. Molnupiravir is taken in pill form. All other FDA-backed treatments against the disease require an IV or injection.

According to the pharmaceutical company, if given the greenlight, molnupiravir would be used for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.

Merck reported earlier this month that the pill cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.

"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,” said Robert M. Davis, chief executive officer and president of Merck. “We are grateful to the patients and investigators in our study, and of course to our own colleagues who have exemplified Merck’s high standards of scientific excellence and our unwavering commitment to patients."

Side effects were similar between patients who got the drug and those in a testing group who received a dummy pill. But Merck has not publicly detailed the types of problems reported, which will be a key part of the FDA’s review.

Merck and its partner, Ridgeback Biotherapeutics, said they are also actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.

In anticipation of the drug's authorization or approval, Merck said it expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022.

Provided that FDA authorization is granted, the U.S. government has also agreed to buy enough of the pills to treat 1.7 million people, at a price of roughly $700 for each course of treatment. That's less than half the price of the antibody drugs purchased by the U.S. government — over $2,000 per infusion — but still more expensive than many antiviral pills for other conditions.

The Associated Press contributed to this report.