Britain authorizes Merck’s covid-19 treatment pill molnupiravir, in the world’s first approval of drug

“We will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” Merck president Robert M. Davis said in a statement announcing the U.K. approval.

The company has applied to the U.S. Food and Drug Agency for emergency use authorization, while the European Medicines Agency has launched a rolling review of the oral antiviral medicine. It said it was also working to submit applications to other regulatory agencies.

A global clinical trial showed the pill reduced hospitalizations and deaths by nearly half among higher-risk adult coronavirus patients diagnosed with mild to moderate illness, Merck — which worked on the drug with partner Ridgeback Biotherapeutics — said last month. The first dose given to a volunteer in the trial was administered in the U.K.

Suerie Moon, co-director of the Global Health Center at the Graduate Institute of Geneva, called the U.K. authorization “a big step forward.”

“I would say it’s very significant in terms of giving patients and the public a large confidence that this treatment can be widely used,” she said.

The U.K. has been known during the pandemic for its speed in authorizing vaccines. The country became the first in the world to approve a coronavirus vaccine that had been tested in a large clinical trial when it granted emergency-use authorization to the Pfizer BioNTech vaccine last December.

The U.S. government has made an advance purchase of 1.7 million courses of molnupiravir at a cost of roughly $1.2 billion, or roughly $700 per treatment course. Australia, Singapore and South Korea have also made purchase agreements.

The company said it expects to produce 10 million courses of the treatment by the end of this year and at least 20 million in 2022. Merck said it will adopt a “tiered pricing approach” that takes into account each country’s ability to pay for the drug.

The firm has also agreed to share its license for the pill with several Indian drugmakers and with a U.N.-backed nonprofit to allow the drug to be manufactured around the world and help increase access to more than 100 low- and middle-income countries. The move stood out in a pandemic that has seen drugmakers lobbying to keep rights to vaccines.

Some advocacy organizations, however, have criticized Merck for leaving out upper-middle-income countries that have been hit hard by the pandemic.

Molnupiravir works by introducing genetic errors that garble the coronavirus’s genetic code and prevent it from making copies of itself.

Virologists have said they are hopeful that in addition to decreasing the risk of developing severe illness, the drug could help reduce transmission of the virus as well. The pill is notably easy to use compared to monoclonal antibodies, a costly treatment that is infused or injected.

The window in which the treatment can be administered and still work appears to be narrow, though. Doctors maintain that vaccines remain the principal tool to fight the coronavirus, as they seek to help prevent people from catching the virus rather than treating it after infection.