Merck Appeals for EUA

The extraordinary impact of this pandemic demands that we move with unprecedented urgency …

Merck CEO Robert Davis requesting emergency use authorization from the FDA for Merck’s antiviral pill for high-risk adults.

• The drug’s name: molnupiravir.
  
• The drug was tested on those with mild-to-moderate cases of COVID-19.
  
• The company says its research shows a reduction of serious/severe COVID-19 (i.e., hospitalization) by 50%.
  
• Why It Matters: In Oct. 2020, the FDA approved the antiviral remdesivir for the treatment of COVID-19 in those “requiring hospitalization.” However, remdesivir has to be administered at a hospital or “healthcare setting” intravenously – not pill form – and is only for more severe cases. If granted emergency use authorization, molnupiravir would be the first antiviral pill available for use in high-risk adults, specifically with mild-to-moderate COVID-19 cases. This could be the start of more oral antivirals coming to market; Pfizer says they also have one and could appeal for its emergency use authorization by the end of the year.

Merck asks FDA to authorize antiviral Covid pill for emergency use

Here’s the SmartHER News card stack with more context on the pill.