US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) has announced receiving emergency conditional approval from the National Medical Products Administration (NMPA) for its oral COVID-19 therapy Lagevrio (molnupiravir). The drug is approved for the treatment of adult patients with mild to moderate COVID-19 who have high-risk factors for severe disease progression, such as old age, obesity or being overweight, chronic kidney disease, diabetes, serious cardiovascular disease, chronic obstructive pulmonary disease, active cancer, and others.
Mechanism of Action and Clinical Data
Molnupiravir, a prodrug of ribonucleoside analog β-D-N4-hydroxycytidine (NHC) co-developed by Ridgeback Therapeutics, has demonstrated activity against coronaviruses and other RNA viruses. Its pharmacological mechanism involves interfering with the viral gene coding to induce errors, thereby preventing virus replication. Data has shown that the risk of hospitalization for patients receiving molnupiravir is reduced by 50%.
Global Approvals and Supply Agreements
The drug obtained Emergency Use Authorization (EUA) in the US in December last year for use in COVID-19-positive adult patients with high progression risk who are unable to obtain or are not clinically suitable for other therapies. In January this year, MSD entered into an agreement with the Medicines Patent Pool (MPP) and 27 generic drug makers, including Chinese companies Fosun Pharma, Langhua Pharma, Lonzeal Pharma, BrightGene, and Desano Bio, to supply the drug to 105 low-and middle-income countries.
Molnupiravir has obtained marketing approvals or EUAs in the US, European Union, Australia, Japan, South Korea, Hong Kong, and Taiwan, among a total of 40 countries or regions. As of December 2022, MSD has supplied 9 million courses of the drug worldwide, treating 2.7 million patients. MSD also struck a cooperation framework agreement with China National Pharmaceutical Group Co., Ltd (Sinopharm), granting the latter exclusive importing rights to the drug in China, and entered a distribution agreement regarding import and distribution in China in November.-Fineline Info & Tech
