BRIEF—Japan latest to approve molnupiravir for SARS-CoV-2 Infection

Merck & Co, known as MSD outside the USA and Canada, and Ridgeback Biotherapeutics have 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.

In Japan, Lagevrio is the planned trademark for molnupiravir, which is available in certain markets outside the USA as Lagevrio.

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.

Molnupiravir was the first oral COVID-19 antiviral medicine to receive authorization on November 4, from the UK’s Medicines and Healthcare Products Regulatory Agency (HRA). It subsequently gained emergency use authorization in the USA, and 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.