First oral antiviral for COVID-19 approved in UK

The manufacturer of molnupiravir, MSD, says it is 'taking immediate action to begin the delivery of molnupiravir' and expects to ship medicine to the UK 'within a month'. The government is yet to confirm how the drug will be rolled out for NHS use.

Molnupiravir has been authorised for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness – including obesity, older age (>60 years), diabetes, or heart disease.

Clinical trial data shows that molnupiravir is most effective when taken during the early stages of infection and so the MHRA recommends its use as soon as possible following a positive COVID-19 test and within five days of symptom onset.

The regulator made clear that the treatment is 'not intended to be used as a substitute for vaccination against COVID-19'.

Rigorous review

MHRA chief executive Dr June Raine 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.

'Lagevrio is another therapeutic to add to our armoury against COVID-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously. This is important, because it means it can be administered outside of a hospital setting, before COVID-19 has progressed to a severe stage.'

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.'

Molnupiravir is a ribonucleoside analogue that interferes with replication of the SARS-CoV-2 virus. It works in a different way to the injectable COVID-19 antiviral remdesivir (Veklury), which is also a nucleoside analogue.