Merck Requests FDA Authorization for COVID-19 Pill

Merck & Co. filed an application requesting FDA authorization for its COVID-19 pill, a huge step toward lessening the blow of symptoms. 

As previously reported by Human Events News, Merck & Co. and its partner Ridgeback Biotherapeutics said their experimental pill helped to prevent high-risk people from becoming seriously sick and dying, cutting the risk of hospitalization or death by about 50 percent. 

The drug, called molnupiravir, was performing so well in its late-stage trial that Merck and Ridgeback stopped enrolling subjects. If cleared, the pill would be the first oral antiviral option on the market and would work like Tamiflu but for COVID-19. 

“The ability to take what is a devastating disease like covid-19 and potentially make it a manageable situation through what is a very convenient round of administration, which is an oral pill you can take at home, has important implications for the ability to manage the ongoing pandemic,” Chief Executive Rob Davis said. 

Merck said it expects to produce 10 million courses of the treatment by the end of the year, and plans to make the pill available globally. 

The FDA could clear the antiviral in the next couple of weeks, and possibly in time for what some health experts expect could be another trying winter, the Wall Street Journal reports. 

“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,” Davis said. 

A course of the treatment is 40 pills, eight a day for five days, started within five days of showing symptoms. 

The emergency-use authorization requested by Merck and Ridgeback is different from a full approval. In the case of emergency-use, manufacturers may distribute products during public-health emergencies based on the best available evidence at the time.

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