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The UK Medicines and Healthcare Products Regulatory Agency (MHRA) authorizes Lageviro.

Read time: 1 mins
Published:5th Nov 2021
Merck Inc.,and Ridgeback Biotherapeutics announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness.

In the U.K., Lageviro (lah-GEV-ree-oh) is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved.

The authorization is based on positive results from a planned interim analysis from the Phase III MOVe-OUT clinical trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized, unvaccinated adult patients with laboratory-confirmed mild-to-moderate COVID-19, symptom onset within five days of study randomization and at least one risk factor associated with poor disease outcomes (e.g., heart disease, diabetes).

Merck announced its application with the FDA for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application. Merck is actively working to submit applications to other regulatory agencies around the world.

Condition: Coronavirus/COVID-19 Infection
Type: drug

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