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EU Drug Regulator Backs Emergency Use Of Merck’s Covid Antiviral Pill

By News Creatives Authors , in Business , at November 19, 2021

Topline

The European Medicines Agency, the European Union’s drug regulator, has signed off on emergency use of Merck’s Covid antiviral pill for adults who have tested positive as it prepares to make a decision on full approval by the end of the year, it said Friday.

Key Facts

The human medicines committee of the EMA said in a statement that Merck’s pill “can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19.”

The pill, which Merck developed with Ridgeback Therapeutics,  should be administered within five days of the onset of symptoms or promptly after diagnosis of Covid, and taken twice a day for five days, the EMA said.

Key Background

Earlier this month, the U.K. became the first country to authorize Merck’s antiviral pill. According to the drugmaker, trials showed the drug reduced the risk of hospitalization or death by half. In the U.S., the Food and Drug Administration is scheduled to convene on November 30 to discuss the drug. The FDA has not set a meeting to discuss Pfizer’s antiviral pill.

What We Don’t Know

Will vaccinated people be eligible to take Merck’s antiviral pill in the U.S.? That is a question the FDA can answer, the drugmaker said, the New York Times reports.

Tangent

The U.S. government on Thursday inked a deal to purchase 10 million courses of Pfizer’s Covid pill. The U.S. has also signed two deals with Merck to purchase a total 3.1 million courses of antiviral pills.  

Further Reading

EU drug regulator aims to conclude Merck COVID-19 antiviral pill approval by the end of 2021 (Reuters)

U.S. Inks $5.3 Billion Deal For Pfizer’s Antiviral Covid Pill — Growing Its Stockpile Of New Coronavirus Treatments (Forbes)

Merck’s Covid Pill Molnupiravir Authorized For First Time In The U.K. (Forbes)

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