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Merck and Ridgeback Biotherapeutics' oral antiviral medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo in a Phase III clinical study.
Merck, known as MSD outside of the United States and Canada, and Ridgeback Therapeutics announced on Oct. 1st, 2021, that their investigational oral antiviral medicine molnupiravir significantly reduced severe outcomes associated with COVID-19. According to a planned interim analysis, molnupiravir reduced the risk of hospitalization or death by 50% in non-hospitalized adult COVID-19 patients with mild-to-moderate symptoms.
According to a company press release, 7.3% of patients who received molnupiravir (28/385) were either hospitalized or died through Day 29 of the study. Conversely, 14.1% of patients given placebo (53/377) were either hospitalized or died as a result of COVID-19 through Day 29. Additionally, no patients that were given molnupiravir died, whereas eight of those given the placebo did.
As a result of the positive findings, Merck will be stopping the study early at the behest of an independent data monitoring committee. Merck plans to submit an application for an emergency use authorization to FDA as soon as possible.
“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 Robert M. Davis, CEO and president, Merck, in the press release. “Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”
“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, CEO of Ridgeback Biotherapeutics, in the press release. “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.”