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11 Oct, 2021 11:51

Merck files in US for emergency FDA authorization for Covid treatment pill after trial data showed it cut hospitalizations in half

Merck files in US for emergency FDA authorization for Covid treatment pill after trial data showed it cut hospitalizations in half

Merck and its partner Ridgeback Biotherapeutics announced on Monday that they've submitted an emergency authorization application to the US Food and Drug Administration (FDA) for their oral antiviral Covid treatment molnupiravir.

The US-based pharmaceutical company revealed the request had been made to the FDA, with the hope that it will become the first authorized oral antiviral Covid treatment following positive results from Merck’s Phase 3 clinical trial.

“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 within 10 days of receiving the data,” Merck’s chief executive officer and president, Robert M. Davis, stated in a press release on the company’s website. 

Merck described the development as a “critical step” towards making the treatment available to individuals at home, reducing the risk of severe illness and cutting in half the hospitalization rates among individuals infected with the virus.

In the hope that the drug will be given the green light by the FDA, Merck has already begun producing the treatment, expecting to have 10 million courses of molnupiravir ready for distribution by the end of 2021, with more due in 2022. 

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Anticipating Merck’s successful trials, the US government ordered 1.7 million courses of molnupiravir, as part of a procurement agreement earlier this year, with other supply and advance-purchase deals similarly signed off with countries around the world.

To help boost the production of the treatment, allowing it to be more quickly distributed in low and middle income countries, Merck has agreed a non-exclusive voluntary licensing agreement with Indian manufacturers, hoping to secure authorization to ensure widespread access to the medicine.

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