Britain OK’s first authorization for COVID pill
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-middleincome 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 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 higherrisk adult coronavirus patients diagnosed with mild to moderate illness, according to Merck, which developed the drug with Ridgeback Biotherapeutics after a discovery 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 older than 60 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 PfizerBioNTech
shot last December.
Suerie Moon, co-director of the Global Health Center in Geneva, said the first approval of molnupiravir is “very significant in terms of giving patients and the public at large confidence that this treatment can be widely used.”
William Fischer, a pulmonary and critical-care physician and professor at the University of North Carolina at Chapel Hill, said the pill presents a chance to help overcome the inequities in access to treatment and prevention of the virus that have marked the pandemic.
The pill is notably easy to use compared with monoclonal antibodies, a costly treatment that is infused or injected.
“Supply and the ability to provide these monoclonal antibodies is extraordinarily limited to really resource-rich countries,” said Fischer, who helped lead the Phase 2 clinical trial of molnupiravir.
He added, “This pill does play a really important role in terms of making sure that people have equal access to care.”
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. And, since the pill can be picked up from a pharmacy and taken at home, Fischer said it will help prevent hospitals from becoming overwhelmed by COVID-19 patients and having to put off other types of care.
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. drugmaker said that 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 U.K. approval marks “an important step,” Hervé Verhoosel, spokesman for Unitaid, a global health agency hosted by the World Health Organization, said in a statement.
“One of the most pressing challenges is now to guarantee a quality-assured generic market at lowest possible price and as rapidly as possible after relevant authorizations for all low- and middle-income countries,” Verhoosel said.