Britain on Thursday became the first country in the world to approve a potentially game-changing Covid-19 antiviral pill jointly developed by US-based Merck and Ridgeback Biotherapeutics, in a boost to the fight against the pandemic.
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 comes ahead of potential US regulatory clearance. US advisers will meet this month to vote on whether molnupiravir should be authorised.
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.
Molnupiravir, 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.
Prof. 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. A wider rollout will follow if it is shown to be clinically and cost effective in reducing hospitalisations and death, he added.
“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,” UK vaccines minister Maggie Throup told parliament.
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 were up 2.1% at $90.54 before the market open.
Pfizer and Roche are also racing to develop easy-to-administer antiviral pills for Covid-19. Pfizer last month began a large study of its oral antiviral drug for the prevention of Covid-19 in people exposed to the coronavirus.
Merck's molnupiravir is also being studied in a late-stage trial for preventing infection.
Viral sequencing done so far has shown molnupiravir is effective against all variants of the coronavirus, Merck has said, including the more-infectious Delta, which is responsible for the worldwide surge in hospitalisations and deaths recently.
While it is not yet clear when Merck will deliver doses to Britain, the company has said it is committed to providing timely access to its drug globally with plans for tiered pricing aligned with a country's ability to pay.
Merck is also in talks with generic drugmakers about expanding manufacturing licences to build supply of the treatment.
Antibody cocktails like those from Regeneron and Eli Lilly have also been approved for non-hospitalised Covid-19 patients, but have to be given intravenously.