Regulators in Britain granted approval to the experimental drug molnupiravir from U.S. pharmaceutical giant Merck on Thursday, marking the first authorization from a public health body for an oral antiviral treatment for covid-19 in adults.
Experts have said that if widely authorized, the medicine could have huge potential to help fight the coronavirus pandemic: Pills are easier to take, manufacture and store, making them particularly useful in lower- to middle-income countries with weaker infrastructure and limited vaccine supplies.
“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.
The company, which added that it would submit applications to other regulatory agencies, has applied to the U.S. Food and Drug Administration for emergency use authorization, while the European Medicines Agency has launched a rolling review of the drug.
“Today is a historic day for our country,” British Health Secretary Sajid Javid said in Thursday’s announcement. “This will be a game changer for the most vulnerable … who will soon be able to receive the ground-breaking treatment.”
In a global clinical trial, the pill reduced hospitalizations and deaths by nearly half among higher-risk adult coronavirus patients diagnosed with mild to moderate illness, according to Merck, which developed the drug with Ridgeback Biotherapeutics after it was discovered at Emory University. The first dose given to a volunteer in the trial was in the United Kingdom.
The U.K. medicines regulator approved the use of the treatment in people who are above 60 years old or have at least one other factor that puts them at risk of covid-19 developing into severe illness, such as obesity and heart disease. The agency found it “safe and effective” at curbing the risk after “a rigorous review.”
Britain became known during the pandemic for its speed in authorizing vaccines. It was the first country in the world to approve a coronavirus vaccine tested in a large clinical trial when it granted emergency-use authorization to the Pfizer-BioNTech shot last December.
The United States has made an advance purchase of 1.7 million courses of molnupiravir at a cost of about $1.2 billion, or roughly $700 per treatment course. Other countries have also reached agreements with Merck to buy the pills, including Australia, Singapore and South Korea.
The U.S. drugmakersaid it expects to produce 10 million courses of the treatment by the end of this year, along with at least 20 million in 2022, and that it plans to adopt a “tiered pricing approach” taking into account each country’s ability to pay.
The firm has also agreed to share its license for the pill with several Indian manufacturers and with a U.N.-backed nonprofit organization to allow production around the world and help boost access to more than 100 low- and middle-income countries.
The move stood out in a pandemic that has seen pharmaceutical companies lobbying to keep rights to vaccines. Some advocacy organizations, however, have criticized Merck for leaving out upper-middle-income countries hit hard by the pandemic.
Suerie Moon, co-director of the Global Health Center in Geneva, described the first approval of molnupiravir as “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 drug — which received a type of conditional market authorization for products that fulfill an unmet medical need — will go by the name Lagevrio in Britain. It works by introducing errors that garble the genetic code of the virus and prevent it from making copies of itself. The window in which it can be administered and still work may be narrow, though, and the British regulator recommended taking it “as soon as possible” after a positive coronavirus test and within five days of symptoms onset.
The U.K. health secretary, Javid, called it “an excellent addition to our armory,” while urging people to keep getting their covid-19 shots. Doctors maintain the vaccines remain the principal tool against the coronavirus, as they seek to help prevent people from catching it rather than treating the disease after infection.
The pill is notably easy to use compared to monoclonal antibodies, a costly treatment that is infused or injected. Virologists have said they are hopeful that as well as limiting the risk of developing severe illness, the treatment could help reduce transmission of the virus too.