Merck’s regulatory submission for molnupiravir is based on positive results from the interim analysis of Phase 3 MOVe-OUT clinical trial
Merck seeks FDA authorisation for molnupiravir. (Credit: Merck KGaA, Darmstadt, Germany.)
Merck has filed an application with the US Food and Drug Administration (FDA) seeking Emergency Use Authorisation (EUA) for its investigational oral antiviral molnupiravir.
The submission indicates the drug for the treatment of mild-to-moderate Covid-19 in adults who are at risk for disease progressing or hospitalisation.
Molnupiravir was discovered by Drug Innovations at Emory (DRIVE), a not-for-profit biotechnology company of Emory University, and was licensed by Ridgeback.
Merck, in collaboration with Ridgeback, is developing the drug for the treatment of non-hospitalised patients with confirmed Covid-19.
Ridgeback Biotherapeutics CEO Wendy Holman 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 antiviral 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 U.S. and around the world.”
The regulatory submission to US FDA is based on positive results from the interim analysis of the Phase 3 MOVe-OUT clinical trial.
In the interim analysis, molnupiravir reduced the risk of hospitalisation or death in at-risk, non-hospitalised adult patients with Covid-19, by around 50%.
Also, the treatment using molnupiravir has resulted in no deaths, compared to eight deaths in people who received placebo, said the company.
In April this year, Merck has signed non-exclusive voluntary licensing agreements with five Indian generics manufacturers for its molnupiravir.
In June this year, the company reached a procurement agreement with the US government to supply 1.7 million courses of its Covid-19 drug to the US, for $1.2bn.
Merck president and CEO Robert Davis said: “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.”
In a separate development, Merck has launched its new cosmetic ingredient RonaCare Epintegrity, to help the skin maintain the integrity of the epidermis.