Home NMPA Conditionally Approves Merck's Oral Antiviral Molnupiravir Capsules for Emergency Use in High-Risk COVID-19 Patients

NMPA Conditionally Approves Merck's Oral Antiviral Molnupiravir Capsules for Emergency Use in High-Risk COVID-19 Patients

Dec 30, 2022 15:41 CST Updated 15:41
MSD

Pharmaceutical R&D and Manufacturer

According to the website of the National Medical Products Administration, on December 29, the National Medical Products Administration, in accordance with the relevant provisions of the Drug Administration Law and the special drug approval procedure, conducted an emergency review and approval, and conditionally approved the import registration of MSD's coronavirus treatment drug Molnupiravir Capsules (trade name: LAGEVRIO).

This product is an oral small-molecule medication for the treatment of COVID-19, used to treat adult patients with mild to moderate Coronavirus Disease 2019 (COVID-19) who have risk factors for progression to severe disease, such as advanced age, obesity or overweight, chronic kidney disease, diabetes, severe cardiovascular disease, chronic obstructive pulmonary disease, and active cancer. Patients should strictly follow the instructions for use under the guidance of a physician.

The National Medical Products Administration (NMPA) requires the marketing authorization holders to continue conducting relevant research, complete the conditional requirements within the specified timeframe, and promptly submit subsequent research results.