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UK’s MHRA approves first oral antiviral against COVID-19

Merck's Lagevrio has been approved for people with mild to moderate COVID-19 and at least one risk factor for developing severe illness

Merck and Co

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has become the first regulatory agency to approve Lagevrio (molnupiravir), developed by Ridgeback Biotherapeutics and Merck & Co – known as MSD outside the US and Canada.

The antiviral drug is the first oral antiviral drug approved to treat COVID-19. The MHRA has approved its use for those with mild to moderate disease and at least one risk factor for developing severe illness. These risk factors include obesity, older age (>60 years), diabetes mellitus or heart disease.

“This will be a game changer for the most vulnerable and the immunosuppressed, who will soon be able to receive the groundbreaking treatment,” said the UK health and social care secretary, Sajid Javid. “The UK is leading the way to research, develop and roll out the most exciting, cutting-edge treatments."

For Dr June Raine, chief executive at the MHRA, Lagevrio is another therapeutic to add to the 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 a hospital setting, before COVID-19 has progressed to a severe stage.”

Merck is already producing Lagevrio – which is advises is pronounced lah-GEV-ree-oh – and expects to produce 10 million courses by the end of the year and at least 20 million courses in 2022.

The approval is based on results from the phase 3 MOVe-OUT clinical trial, which showed that molnupiravir reduced the risk of hospitalisation or death by approximately 50% against placebo.

An oral antiviral is seen by many as an essential part of the medical toolkit against COVID-19, as Gilead’s Veklury (remdesivir) and Regeneron’s antibody cocktail REGEN-COV (Ronapreve in Europe) are administered intravenously and so can only be used in hospitals.

Both the US Food and Drug Administration and European Medicines Agency, along with other regulatory bodies around the world, are also reviewing the data on the drug. The US government has already placed an order for1.7 million courses of molnupiravir, to be fulfilled following FDA approval, and Merck has entered into similar agreements with governments worldwide.

The UK government has ordered 480,000 courses, but with the UK seeing around 40,000 cases per day, representing nearly 10% of all global cases of COVID-19, rationing to people most at risk is likely. The UK government will confirm how this COVID-19 treatment will be deployed to patients in due course.

Article by
Hugh Gosling

5th November 2021

From: Regulatory, Healthcare

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