Merck submits FDA emergency approval application for first treatment of COVID-19 in a pill

With much attention on COVID-19 vaccines, including efforts to gain approval for children under the age of 12, pharmaceutical giant Merck has been pursuing the first oral antiviral medicine for the treatment of the virus.

A pursuit that culminated on Monday when Merck and its partner Ridgeback Biotherapeutics announced that it has applied for emergency approval from the Food and Drug Administration for its COVID-19 pill, called molnupiravir. Merck’s CEO Robert Davis pointed to “compelling results” in clinical trials that show molnupiravir cuts the risk of hospitalization or death in patients with mild to moderate COVID-19 by about 50 percent.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world,” Davis said in an Oct. 1 press release. “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most.”

The new drug is expected to substantially reduce hospitalizations, according to Wendy Holman, chief executive officer of Ridgeback Biotherapeutics.

“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Holman said.

Because of the positive results, Merck and Ridgeback Biotherapeutics halted enrollment in its late-stage trial after discussions with the Food and Drug Administration. This also prompted the announcement Monday that an application for emergency approval has been filed.

“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 in a statement Monday. “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.”

“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 — medicines and vaccines are both essential to our collective efforts,” the release continued. “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.”

Last week, Pfizer became the first vaccine maker to apply for emergency use authorization of its coronavirus vaccine in kids ages 5-11, U.S. News reported, adding that U.S. health officials “have pledged to act quickly on the request.”

Pfizer announced “positive topline results” from its trial in children ages 5-11 in September, according to US News, reporting the vaccine was “safe, well tolerated and showed robust neutralizing antibody responses.”

While children are at lower risk of severe infection and death from COVID-19 than older populations, the article noted that if approved, the development “could open up the shot to 48 million more people.” Approval, if granted, is expected in November, if not late October.

Tom Tillison


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