DTMT Network

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has granted authorisation to Molnupiravir (oral antiviral) for treating adult COVID-19 positive patients with mild to moderate symptoms in the United Kingdom, the (U.K.), Merck has informed.

Other regulatory agencies including European Medicines Agency and the United States Food and Drug Administration are still reviewing the company’s application for authorisation, the company added.

Robert M. Davis, the Chief Executive Officer and President of Merck, said “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.”

“We will continue to move with both rigour and urgency to bring molnupiravir to patients around the world as quickly as possible,” he added.

The results from phase three of a multicentre clinical trial have been the basis of the authorisation, the statement from the company read.

In the course of the trial, unvaccinated, non hospitalised adult COVID-19 positive patients with mild to moderate symptoms were given molnupiravir 800 mg twice-daily dose within five days of onset of symptoms.

The statement further added that the patients with existing at least one risk factor such as heart disease, diabetes, etc. were chosen for the trial.

Thanking the investigators and participants and their families, who took part in the trials, Dean Y. Li, the President, Merck Research Laboratories said that “As an oral therapeutic, molnupiravir offers an important addition to the vaccines and medicines deployed so far to counter the COVID-19 pandemic.”