The MHRA has authorised Merck and Ridgeback Biotherapeutics’ molnupiravir pill for the treatment of at-risk Covid-19 patients, following positive clinical trial results.
Molnupiravir is the first oral antiviral medicine authorised 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 UK, Lagevrio is the planned trademark for molnupiravir, while the trademark for use in other countries has not yet been approved. Merck said that its application with the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency (EMA) has initiated a rolling review of the company’s Marketing Authorization Application. Merck is submitting applications to other global regulatory agencies.
“The first global authorisation of molnupiravir is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges. In pursuit of Merck’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” said Robert Davis, CEO and President of Merck.
“As an oral therapeutic, molnupiravir offers an important addition to the vaccines and medicines deployed so far to counter the Covid-19 pandemic,” said Dr Dean Li, Executive Vice President and President of Merck Research Laboratories.
The authorisation 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-hospitalised, unvaccinated adult patients with laboratory-confirmed mild-to-moderate Covid-19, symptom onset within five days of study randomisation and at least one risk factor associated with poor disease outcomes (e.g., heart disease, or diabetes).