With UK nod, Merck drug becomes world's 1st pill for Covid treatment

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) on Thursday approved antiviral medication molnupiravir 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.

The risk factors include obesity, older age (above 60 years), diabetes mellitus and heart disease.

The MHRA recommended the use of Covid-19 drug molnupiravir as soon as possible following a positive Covid-19 test and within five days of symptoms onset.


It said based on clinical trial data, the drug is found to be most effective when taken during the early stages of the infection.

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, the MHRA said.

"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 of health and social care at 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 authorisation is based on positive results from a planned interim analysis from a phase-3 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.

MSD and partner Ridgeback Biotherapeutics said their application with the US Food and Drug Administration for Emergency Use Authorisation of molnupiravir is under review and that recently the European Medicines Agency has initiated a rolling review of their marketing authorisation application.

MSD is actively working to submit applications to other regulatory agencies around the world.

MSD previously announced that it had entered into a licensing agreement with the medicines patent pool to increase broad access to molnupiravir in low- and middle-income countries.

It also has non-exclusive voluntary licensing agreements with established Indian generic manufacturers to accelerate availability of the drug in more than 100 low- and middle-income countries following approvals or emergency authorisation by local regulatory agencies, the company had said.