Oct. 1 (UPI) — Merck announced Friday it will ask the Food and Drug Administration to grant emergency use authorization for an anti-coronavirus drug that reduced hospitalizations by nearly 50% in clinical trials.
If approved, Molnupiravir, a joint effort between Merck and Ridgeback Biotherapeutics, would become the first orally taken antiviral medicine taken for COVID-19. In a Phase 3 study, 7.3% of patients taking Molnupiravir were hospitalized, while 14.1% of those taking a placebo had to be admitted to the hospital.
“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,” Merck’s CEO and president Robert M. Davis said in a statement.
Merck said in its Phase 3 study, no participants using Molnupiravir died through the first 29 days of the tests, while eight patients using a placebo died.
“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,” Wendy Holman, CEO of Ridgeback, said in a statement.
“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.”
Along with seeking approval from the FDA, Merck said it would seek emergency authorization from other government drug regulatory agencies around the world for use.