Merck's Tamiflu-Like Covid-19 Pill Highly Successful in Key Study; Authorization Could be Granted by End of Year

Merck and Ridgeback Biotherapeutics announced Friday that their experimental Covid-19 pill significantly helped high-risk people in the early stage of infection from becoming seriously ill or dying, a major step in the battle against the pandemic. The pill is on track to become the first at-home, easy-to-use treatment for the coronavirus.

The pill, named molnupiravir, reduced the risk of hospitalization or death by approximately 50 percent. Merck said it has been so effective that the companies — at the recommendation of an independent data monitoring committee and in consultation with the U.S. Food and Drug Administration — stopped enrollment in its late-stage trial early due to the positive results. Merck plans to submit an application for emergency use authorization to the U.S. FDA in the coming weeks based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.

If approved, the drug would be the first oral antiviral drug for Covid-19, becoming a kind of Tamiflu for the virus as it would be a medication taken upon a patient's first signs of symptom development and potentially prevent individuals from becoming seriously ill.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most," said Merck CEO Robert Davis.

“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed,” said Wendy Holman, Ridgeback Biotherapeutics CEO. “We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic."