The risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.
MHRA recommended the use of Molnupiravir as soon as possible following a positive COVID-19 test and within five days of symptoms onset.
MHRA said based on the clinical trial data, Molnupiravir is most effective when taken during the early stages of infection.
MHRA said the approval follows a rigorous review of its safety, quality and effectiveness by the UK regulator and the government’s independent expert scientific advisory body, the Commission on Human Medicines.
“This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment,” said Sajid Javid, Secretary Health and Social Care of the UK government.
Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD), Lagevrio (Molnupiravir) works by interfering with the virus’ replication. This prevents it from multiplying, keeping virus levels low in the body and therefore reducing the severity of the disease.
The authorization is based on positive results from a planned interim analysis from the Phase 3 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).
MSD and its partner Ridgeback Biotherapeutics announced their application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently the European Medicines Agency has initiated a rolling review of the company’s Marketing Authorization Application. MSD is actively working to submit applications to other regulatory agencies around the world.
MSD previously announced that it has entered into a licensing agreement with the Medicines Patent Pool to increase broad access for molnupiravir in low- and middle-income countries. Additionally, MSD previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.