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FDA weighing emergency approval for 1st pill to treat COVID-19

FDA weighing emergency approval for 1st pill to treat COVID-19
Merck said earlier this month that it would ask for emergency authorization after clinical trials showed that molnupiravir reduced coronavirus-related hospitalizations by nearly 50%. File Photo by Justin Lane/EPA

Oct. 11 (UPI) -- Pharma giant Merck on Monday asked U.S. regulators for emergency authorization for an antiviral pill that would be the first tablet in the United States authorized to treat COVID-19.

The company said it has applied to the Food and Drug Administration for emergency use authorization for its medication molnupiravir to treat the coronavirus disease in U.S. adults. Merck has developed the drug with Ridgeback Biotherapeutics.

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If it receives authorization, the pill would be the first antiviral tablet approved on any level in the United States to treat COVID-19.

Other treatments that have been authorized by the FDA are delivered via injection or intravenously.

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Merck said molnupiravir would be a significant step forward in fighting the pandemic, as it would allow for the treatment of COVID-19 at home and is markedly cheaper than other treatments.

Merck said earlier this month that it would ask for emergency authorization after clinical trials showed that molnupiravir reduced coronavirus-related hospitalizations by nearly 50%.

"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA," Merck CEO Robert Davis said in a statement.

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"The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home," added Ridgeback Biotherapeutics CEO Wendy Holman.

A pill treatment for COVID-19 would add a weapon against the pandemic and perhaps offer a new line of protection for tens of millions of Americans who have so far refused a coronavirus vaccine.

The FDA is expected to make a determination on molnupiravir within a couple weeks. The agency will weigh the companies' data concerning the drug's effectiveness, safety and side effects.

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Emergency use authorization allows widespread distribution of a certain drug during a public health emergency before all clinical trials are completed. To grant authorization, the FDA must determine that a drug's proven or potential benefits outweigh the known and potential risks.

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