U.K. authorizes Merck antiviral pill, 1st shown to treat COVID-19
LONDON — Britain granted conditional authorization on Thursday to the first pill shown to successfully treat COVID-19 so far. It also is the first country to OK the treatment from drugmaker Merck, although it wasn’t immediately clear how quickly the pill would be available.
The pill was licensed for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug, known molnupiravir, twice a day for five days.
An antiviral pill that reduces symptoms and speeds recovery could prove groundbreaking, easing caseloads on hospitals and helping to curb outbreaks in poorer countries with fragile health systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
Molnupiravir is also pending review with regulators in the U.S., the European Union and elsewhere. The U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize
the pill’s safety and effectiveness in late November.
Initial supplies will be limited. Merck has said it can produce 10 million treatment courses through the end of the year, but much of that supply has already been purchased by governments worldwide.
In October, U.K. officials announced they secured 480,000 courses of molnupiravir and expected thousands of vulnerable Britons to have access to the treatment this winter via a national study.
“Today is a historic day for our country, as the U.K. is now the first country in the world to approve an antiviral that can be taken at home for COVID-19,” British health secretary Sajid Javid said.
“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” he said
in a statement, referring to the U.K.’s National Health Service. Doctors said the treatment would be particularly significant for people who don’t respond well to vaccination.
Merck and partner Ridgeback Biotherapeutic have requested clearance for the drug with regulators around the world for adults with early cases of COVID-19 who are at risk for severe disease or hospitalization. That’s roughly the same group targeted for treatment with infused COVID-19 antibody drugs, the standard of care in many countries for patients who don’t yet require hospitalization.
Merck announced preliminary results in September showing its drug cut hospitalizations and deaths by half among patients with early COVID19 symptoms. The results haven’t yet been peer reviewed or published in a scientific journal.