First Oral Antiviral for COVID-19, Lagevrio (Molnupiravir), Approved By MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) announced today that the antiviral Lagevrio (molnupiravir) is safe and effective at reducing the risk of hospitalisation and death in people with mild to moderate COVID-19 who are at increased risk of developing severe disease.

This 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, making it the first oral antiviral for the treatment of COVID-19 to be approved.

The health and social care secretary Sajid Javid said “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.

Dr June Raine, MHRA chief executive, said “following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe COVID-19 disease and have granted its approval.

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