UK approves Merck’s antiviral COVID pill molnupiravir in world first

Molnupiravir targets an enzyme the coronavirus uses to reproduce itself.(Reuters: Merck
Britain has become the first country in the world to approve Merck’s potentially game-changing COVID-19 antiviral pill.
Key points:
- US advisers will meet this month to vote on whether molnupiravir should be authorised
- Australia has already ordered 300,000 courses
- Merck is expecting to produce 10 million courses by the end of this year
The pill was licensed for adults 18 and older who have at least one risk factor for developing severe disease, such as obesity or heart disease.
It is the first oral antiviral treatment for COVID-19 to get approved, with the green light coming ahead of potential US regulatory clearance.
US advisers will meet this month to vote on whether molnupiravir should be authorised.
Australia’s Therapeutic Goods Administration has not yet approved the drug but the federal government announced last month it had ordered 300,000 courses.
“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,” said Britain’s health secretary, Sajid Javid.
“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible.”
The British government and the country’s National Health Service have not yet confirmed how the treatment will be deployed to patients.
Last month, Britain agreed to a deal with Merck to secure 480,000 courses of molnupiravir.
In a separate statement, Merck said it was expecting to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.
The company and its partner Ridgeback Biotherapeutic have requested clearance for the drug with regulators around the world to treat adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalisation.
Merck’s preliminary results last month have not yet been peer reviewed or published in a scientific journal.
The company also did not disclose details on molnupiravir’s side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.
The drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells.
ABC