Merck's oral novel coronavirus drug Molnupiravir was approved！
2021-11-05
On November 4, Merck/Ridgeback announced that the British Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the marketing of Molnupiravir (MK-4482, EIDD-2801) in the UK for the treatment of adult patients with mild to moderate COVID-19. Molnupiravir is the world's first oral antiviral drug approved for the treatment of mild to moderate COVID-19 in adults. These patients have tested positive for SARS-CoV-2 and have at least one risk factor for developing a serious disease.
This approval is mainly based on data from the Phase III MOVe-OUT study. The first treatment patients took molnupiravir and placebo. The hospitalization/death ratio within 29 days was 7.3% (28/385) in the molnupiravir treatment group and 14.1% (53/377) in the placebo control group, p=0.0012. The risk of hospitalization and death in the molnupiravir treatment group was reduced by 50%, and no deaths were reported within 29 days, and 8 deaths were reported in the placebo control group.
In terms of safety, the incidence of any adverse events in the Molnupiravir treatment group was similar to that in the placebo group (35% vs 40%), and the incidence of drug treatment-related adverse events was also comparable (12% vs 11%). Moreover, the proportion of patients who discontinued treatment due to adverse events in the Molnupiravir group was lower (1.3% vs 3.4%).
Molnupiravir (MK-4482/EIDD-2801) is a nucleoside analog discovered by DRIVE (Drug Innovations at Emory), a non-profit organization affiliated to Emory University, which inhibits the activity of SARS-CoV-2 replication. It is 3-10 times higher, and has shown activity in a number of preclinical SARS-CoV-2 virus infection prevention, treatment and prevention models.
Molnupiravir is currently co-developed by Merck and Ridgeback. Ridgeback received a down payment from Merck and will receive miles based on clinical development and registration progress in the future. In the future, the two companies will share the profits after drug sales.
On June 9 this year, Merck signed a procurement agreement with the U.S. government. Once it obtains emergency use authorization or formal approval from the FDA, it will provide the U.S. government with 1.7 million courses of molnupiravir. Merck has also signed procurement and supply agreements for molnupiravir with other governments around the world, and is currently communicating with more governments.
——Digested from Medicine Cube Plus WeChat Publisher
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