Molnupiravir: Merck & Co Inc's Covid pill approved in the UK
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Last week Britain became the first country in the world to approve the potentially game-changing COVID-19 antiviral pill, jointly developed by US-based Merck & Co Inc and Ridgeback Biotherapeutics, with the Medicines and Healthcare products Regulatory Agency giving it the green light. The Government said in October it had secured 480,000 courses of the Merck drug, as well as 250,000 courses of an antiviral pill developed by Pfizer Inc.
Asked about the molnupiravir approval, Dr Hopkins told BBC television: “That is great news and it will start to be rolled out through a drug trial in the end of this month/the beginning of December.”
Dr Hopkins said all the trials so far had been done with the unvaccinated, so this would help understand how it will work in the wider vaccinated population.
She added: “The new Pfizer drug is probably not going to be licensed until the new year some time.
“It is still likely to be a couple of months away.”
Merck’s treatment 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 on Thursday, 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.
US advisers will meet on Nov. 30 to review the drug’s safety and efficacy data and vote on whether molnupiravir should be authorised.
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.
Drugs in the same class as molnupiravir have been linked to birth defects in animal studies. Merck, known as MSD outside of the United States and Canada, has said animal testing shows that molnupiravir is safe, but the data have not yet been made public.
Treatments to tackle the pandemic, which has killed more than 5.2 million people worldwide, have so far focused mainly on vaccines.
Other options, including Gilead’s infused antiviral remdesivir and generic steroid dexamethasone, are generally only given after a patient has been hospitalised.
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.
Also on Thursday, 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.
(More to follow)
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