The UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorised MSD and Ridgeback Therapeutics’ COVID-19 antiviral medicine molnupiravir.
The UK approval is the first authorisation for molnupiravir in the world, with additional application currently under review including with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
Molnupiravir has been authorised for the treatment of mild-to-moderate COVID-19 in adult patients with a positive test and who have at least one risk factor for developing severe illness.
The antiviral medicine will be marketed with the trademark name Lagevrio in the UK, MSD said in a statement.
The MHRA authorisation is based on positive results from a planned interim analysis from the Phase III MOVe-OUT clinical trial.
This trial evaluated molnupiravir 800mg twice-daily in non-hospitalised, unvaccinated adult patients with lab-confirmed, mild-to-moderate COVID-19 and symptom onset within five days of study randomisation.
All patients in this trial also had at least one risk factor associated with poor disease outcomes, such as heart disease and diabetes.
“The first global authorisation of molnupiravir is a major achievement in MSD’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges,” said Robert M. Davis, chief executive officer and president, MSD.
“In pursuit of MSD’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,” he added.
