Merck and Ridgeback seek Emergency Use Authorisation from US FDA for Molnupiravir

Merck and Ridgeback Biotherapeutics yesterday announced that Merck has submitted an Emergency Use Authorisation (EUA) application to the US Food and Drug Administration (FDA) for Molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalisation. The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorisation in the coming months, Merck said in a statement.

The submission is based on positive results from a planned interim analysis from the phase-III MOVe-OUT clinical trial, which evaluated Molnupiravir in non-hospitalised adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalisation. At the interim analysis, Molnupiravir reduced the risk of hospitalisation or death by approximately 50 per cent; 7.3 per cent of patients who received Molnupiravir were either hospitalised or died through day 29 following randomisation (28/385), compared with 14.1 per cent of placebo-treated patients (53/377); p=0.0012. Through day 29, no deaths were reported in patients who received Molnupiravir, as compared to eight deaths in patients who received placebo. The incidence of any adverse event was comparable in the Molnupiravir and placebo groups (35 per cent and 40 per cent, respectively). The incidence of drug-related adverse events was also comparable (12 per cent and 11 per cent, respectively), and fewer subjects in the Molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3 per cent and 3.4 per cent, respectively).

“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, 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. 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.”

Adding to it, Wendy Holman, Chief Executive Officer, Ridgeback Biotherapeutics, said, “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 anti-viral medicine that can be taken at home shortly after diagnosis with COVID-19. We are pleased to partner with Merck and regulatory authorities to help provide Molnupiravir to the people who need it here in the US and around the world.