UK approves Merck's COVID-19 pill in world first
Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19 antiviral pill jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic, Reuters reported.
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) recommended the drug, molnupiravir, for use in people with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes, and heart disease.
It will be administered as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, the regulator said, citing clinical data.
The green light is the first for an oral antiviral treatment for COVID-19 and the first for a COVID-19 drug that will be administered widely in the community. U.S. advisers will meet on Nov. 30 to review the drug's safety and efficacy data and vote on whether molnupiravir should be authorized.
The pill, which will be branded as Lagevrio in Britain, is designed to introduce errors into the genetic code of the coronavirus that causes COVID-19 and is taken twice a day for five days.
Merck's Molnupiravir has been closely watched since data last month showed it could halve the chances of dying or being hospitalised for those most at risk of developing severe COVID-19 when given early in the illness.
Professor Stephen Powis, national medical director for the National Health Service (NHS) in England, said the drug would be administered to patients at higher risk of complications as Britain heads into one of the most challenging winters ever.
Last month, Britain agreed a deal with Merck to secure 480,000 courses of molnupiravir.
In a separate statement, Merck said it expected 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 U.S.-based drugmaker's shares rose 2.1% to close at $90.54 on Thursday.