Monday, October 18, 2021

Merck seeks emergency use authorization for antiviral COVID-19 drug

October 1 (WNN) — Merck announced Friday that it will ask the Food and Drug Administration to grant emergency use authorization for an anti-coronavirus drug that has reduced hospitalizations in clinical trials by nearly 50%.

If approved, mollupiravir, a joint effort between Merck and Ridgeback Biotherapeutics, would become the first antiviral drug taken orally for COVID-19. In the Phase III study, 7.3% of patients taking molanupiravir were hospitalized, compared to 14.1% of those taking placebo.

“With these compelling results, we are optimistic that molnupiravir could become an important drug as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of pioneering infectious diseases when they are needed most.” Merck CEO and President Robert M Davis said in a statement.

Merck said in its phase 3 study, none of the participants using mollupiravir died during the first 29 days of the trial, while eight patients using a placebo died.

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“With the virus becoming more widely transmitted, and because currently available therapeutic options are infected and/or need access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of hospital is seriously needed, Ridgeback CEO Wendy Holman said in a statement.

“We are very excited by the results of the interim analysis and hope that molanupiravir, if authorized for use, could have a profound impact in controlling the epidemic.”

Along with receiving approval from the FDA, Merck said it would seek emergency authorization from other government drug regulatory agencies around the world for use.

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