Merck, Ridgeback Molnupiravir gets special approval for emergency in Japan

"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.