Britain has become the first country in the world to approve a potential game-changing COVID-19 antiviral pill, which was jointly developed by US based Merck & Co Inc and Ridgeback Biotherapeutics, in its effort to fight the Wuhan Coronavirus.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has recommended the COVID-19 antiviral pill, molnupiravir, for use in those who have been afflicted with mild to moderate COVID-19 and has at least one risk factor for developing severe illness, including heart disease, obesity, and older age diabetes.
“Molnupiravir should be administered as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms,” said the regulator citing clinical data.
Molnupiravir is the world’s first oral antiviral treatment for COVID-19 and the first for a COVID-19 drug that can be administered widely among the populace.
The FDA is scheduled to meet on November 30 to review data revolving around the drug’s safety and efficacy and vote on whether it should be authorized.
Molnupiravir, branded as Lagevrio in Britain, has been designed to introduce errors into the genetic code of the Wuhan Coronavirus; it should be taken twice a day for five days.
Incidentally, 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 stated, animal testing shows molnupiravir is safe; however it has yet to make the data public.
According to Merck’s Molnupiravir data, the pill could slash the chance of death or being hospitalized by 50% for those most at risk of developing severe COVID-19 if treated early.
According to Professor Stephen Powis, national medical director for the National Health Service (NHS), England, the drug would be administered to patients at higher risk of complications even as Britain heads into one of the most challenging winters ever.
He went on to add, a wider rollout will follow if it is clinically and cost effective in reducing hospitalisations and death.
“We are now working across government and the NHS to urgently get this treatment to patients initially through a national study so we can collect more data on how antivirals work in a mostly vaccinated population,” said UK vaccines minister Maggie Throup to the British parliament.
In October, Britain agreed a deal with Merck to secure 480,000 courses of molnupiravir.
“Comments made by Mr Javid today suggest that it may be made available via a clinical trial, presumably to investigate its effectiveness in vaccinated patients with breakthrough infections, as the original study incorporated unvaccinated adults,” said Professor Penny Ward, an independent pharmaceutical physician while adding, the NHS needs to outline its plans for the rollout since supplies are likely to be tight given the strong global demand.
Merck has licensed the drug to generic drugmakers for supply to low-income countries.