Pharmaceutical company Merck announced Monday that they and Ridgeback Biotherapeutics were requesting emergency authorization from the U.S. Food and Drug Administration (FDA) for molnupiravir, its experimental antiviral COVID-19 pill.
“Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, 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,” Merck announced in a press release. “The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.”
The request was based on “positive results from a planned interim analysis” which “evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization.” According to the interim analysis, “molnupiravir reduced the risk of hospitalization or death by approximately 50%.”
“7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo,” the release added.
“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, Merck chief executive officer, and president. “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. 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.”
“We are grateful to the clinical investigators and patients who have helped bring us to this important milestone. Without their significant contributions, today’s achievement would not be possible. 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,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics. “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.”
Merck & Co., Inc. is an American multinational pharmaceutical company based in Kenilworth, New Jersey, with annual revenue of $47.994 billion as of 2020.