An American Pharmaceutical Company Requested FDA Approval for an Antiviral COVID-19 Pill


Source: AP Photo/Kristin M. Hall.


By Madeline Leesman

We’ve covered in recent weeks how pharmaceutical companies are at work to get approval from the Food and Drug Administration (FDA) for Wuhan coronavirus booster shots and vaccines for children. And, as I covered, Pfizer announced last month that it’s in the mid-to-late stage trials for an oral drug to fight against COVID-19. Today, a New Jersey-based pharmaceutical company announced that it requested approval from the FDA for a COVID-fighting pill.

On Monday, pharmaceutical company Merck, along with Ridgeback Biotherapeutics, announced in a press release that it has requested approval from the FDA for Emergency Use Authorization (EUA) for molnupiravir. According to the press release, molnupiravir is “an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.”

The companies’ submission is based on positive results from a planned interim analysis, the Phase 3 MOVe-OUT clinical trial, where they evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate coronavirus. These individuals were at risk of progressing to severe COVID-19 and/or hospitalization. According to the press release, at the interim analysis, molnupiravir decreased the risk of hospitalization or death by approximately 50 percent.

In a statement from Merck, CEO and President Robert Davis applauded the investigators and patients who took part in the study for their “high standards of scientific excellence” and “unwavering commitment.”

“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,” Davis said. “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

In a separate statement, Ridgeback Biotherapeutics CEO Wendy Holman expressed gratitude for everyone who participated in the study and looks forward to receiving FDA approval for molnupiravir.

“The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19,” Holman said. “We are pleased to partner with Merck and regulatory authorities to help provide molnupiravir to the people who need it here in the U.S. and around the world.”

If granted EUA approval, Merck expects to produce 10 million courses of treatment by the end of the year. Earlier this year, Merck entered into a procurement agreement with the federal government under which the company will supply roughly 1.7 million courses of molnupiravir to the government upon approval from the FDA.

“I also want to take this moment to applaud our colleagues in the pharmaceutical industry and our collaborators in global health for rising to the challenge of bringing forward medicines and vaccines to fight COVID-19,” Davis said in his statement. “Medicines and vaccines are both essential to our collective efforts.”