UK Becomes First Country to Approve Merck's Pill to Treat COVID-19

The United Kingdom on Thursday, 4 November, became the first country in the world to approve a Merck's pill for treating COVID-19, making it the first oral antiviral for the treatment of the novel coronavirus.

UK’s Medicines and Healthcare Products Regulatory Agency authorised Molnupiravir for the treatment of the mild-moderate COVID-19 cases, who are at an "increased risk of developing severe disease", the UK government said in press release.

The drug called Lagevrio is developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme (MSD). The MHRA informed that the drug is most effective in the early stages of infection and recommended to use it as soon as one tests positive.

“Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19. This will be a gamechanger for the most vulnerable and the immunosuppressed, who will soon be able to receive the ground-breaking treatment," Health and Social Care Secretary Sajid Javid said.

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, who independently reviewed the data on the pill also endorsed the drug for treating COVID-19.

He said that the drug reduces the risk of hospitalisation and death in mild-to-moderate COVID-19 patients by 50 percent.

However, the drug is not an alternative to vaccination.

Merck and Ridgeback have announced on October 11, the submission of an emergency use authorisation application to the US FDA for the treatment of mild to moderate cases (room air oxygen saturation more than 93 per cent at rest).

Merck has previously announced that it has entered into non-exclusive voluntary licensing agreements for Molnupiravir with six established Indian generic manufacturers to accelerate the availability of the drug in more than 100 low- and middle-income countries (LMIC), following approval or EUA by their respective regulatory bodies.