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UK Authorizes COVID Pill For Treatment of Infected Adults. Will U.S. Approval Be Far Behind?

November 04, 2021

Great Britain granted conditional authorization on Thursday to the first pill shown to successfully treat COVID-19. It is the first country to approve the treatment from drugmaker Merck.

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 as 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 in the United States and elsewhere. The U.S. Food and Drug Administration expects to convene a panel of experts later this month to study the pill’s safety and effectiveness.

Ulysses Wu, MD, Hartford HealthCare System Director of Infectious Disease and Chief Epidemiologist, said Pfizer also has a pill in the approval process. He added that while the drugs show promise in treating people who already have COVID-19, they would do nothing to prevent it.

“I wouldn’t want to call it a breakthrough because it could distract from the main way to treat COVID, which is vaccines,” Dr. Wu said. “Even though it will be very important for this drug to be developed, it should still not be the mainstay, and it’s development may even cause more vaccine hesitancy.”