First pill to treat COVID applies for FDA approval

Merck & Co Inc. has applied for emergency use approval to treat COVID-19 patients with molnupiravir, an oral antiviral medication. The FDA is investigating the safety and effectiveness of the drug—particularly its adverse events—before making an approval decision.

If approved, molnupiravir—developed with Ridgeback Biotherapeutics—would become the first treatment for COVID-19 that does not involve an IV or injection.

Background

The drug’s FDA approval would break new ground in the way COVID-19 is treated because the treatment can be taken at home. Study results reveal molnupiravir halved the death rate in mild-to-moderately ill patients who had at least 1 risk factor for the disease.¹

The interim efficacy data on molnupiravir put a dent in competitor COVID-19 vaccine makers’ shares and set off a scramble to sign a supply deal in several countries.¹

Distribution

Merck is contracted to supply the US government with about 1.7 million courses of the treatment annually at $700 per course. The company is on track to produce 10 million courses by the end of 2021, according to the company.

At more than $2,000 per infusion, molnupirivir is more expensive than many antiviral pills for other conditions.²

In an interview, Nicholas Kartsonis, Sr Vice President of Clinical Research at Merck, said that the $700 per course figure does not represent the drug’s final price.

"We set that price before we had any data, so that is just one contract," Kartsonis said. "Obviously we are going to be responsible about this and make this drug as accessible to as many people around the world as we can."

Merck has also reached an agreement with several generic drugmakers in India who will supply the treatment to more than 100 low- and middle-income nations.¹

References

1. Mishra M, Leo L. Merck seeks first U.S. authorization for COVID-19 pill. Reuters. October 11, 2021. Accessed October 13, 2021. https://www.reuters.com/world/us/merck-applies-us-emergency-authorization-covid-19-pill-2021-10-11/

2. Merck asks FDA for emergency authorization for first pill to treat COVID-19. CBS News. October 11, 2021. Accessed October 13, 2021. https://www.cbsnews.com/news/covid-19-pill-merck-fda-molnupiravir/