Japan’s Ministry of Health, Labor and Welfare Approves Molnupiravir for the Treatment of SARS-CoV-2 Infection

Molnupiravir, First Oral COVID-19 Antiviral Medicine To Receive Authorization in the World, Now Authorized in U.S., U.K. and Japan; Regulatory Submissions Are Under Review Around the World

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that Japan’s Ministry of Health, Labor and Welfare has granted Special Approval for Emergency in Japan for molnupiravir, an investigational oral antiviral medicine, for infectious disease caused by SARS-CoV-2. Special Approval for Emergency is the process under Article 14-3 of the Pharmaceuticals and Medical Devices Act to approve a medical product swiftly in an emergency situation to protect public health. Under a previously announced supply agreement, the Japanese government will purchase 1.6 million courses of molnupiravir to accelerate access to patients.

“As a single oral medicine that can be taken at home, early treatment with molnupiravir significantly reduced the risk of hospitalization or death in patients at high risk for progressing to severe COVID-19. Importantly for patients, there were markedly fewer deaths among those taking molnupiravir in our clinical study. We believe that molnupiravir will be a critical addition to the measures available to help curb the impact of COVID-19 on patients, healthcare systems and public health in Japan,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “All of us at Merck have embraced our responsibility to bring this important medicine forward to patients globally as quickly as possible.”

“We are proud to reach this important milestone alongside our collaborators, patients and physicians,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “We are confident in the promise of molnupiravir as a medicine that can be taken at home with no known drug-drug interactions and believe it will have a positive impact as part of the global effort to fight the COVID-19 pandemic.”

Molnupiravir was the first oral COVID-19 antiviral medicine to receive authorization on Nov. 4, when the U.K.’s Medicines and Healthcare Products Regulatory Agency granted authorization. In the E.U., the European Medicines Agency issued a positive scientific opinion for molnupiravir under Article 5.3 regulation 726/2004, which is intended to support national decision-making on the possible use of molnupiravir prior to marketing authorization. On Dec. 23, the U.S. Food and Drug Administration granted Emergency Use Authorization for molnupiravir. Regulatory applications are under review or are in the process of being submitted for molnupiravir around the world.

In Japan, LAGEVRIO^® (molnupiravir) is the planned trademark for molnupiravir. Molnupiravir is available in certain markets outside the U.S. as LAGEVRIO.