Merck and Ridgeback Biotherapeutics applied for an FDA emergency use authorization (EUA) for the investigational oral antiviral medicine, molnupiravir, to treat patients with mild-to-moderate Covid-19 infection who are at risk for progressing to severe infection or hospitalization.
This announcement come a little over a week after the manufacturers touted positive results from an interim analysis of the phase III MOVe-OUT clinical trial, which found that molnupiravir reduced risk of hospitalization or death by around 50% in patients with Covid-19, as previously reported by BreakingMED.
“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” said Robert M. Davis, Merck president and CEO, in a company press release. “… We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”
If the FDA decides to grant the EUA for molnupiravir, it may become the first oral antiviral medication authorized to treat patients with Covid-19, as well as the second antiviral drug authorized for the virus overall, after remdesivir.
Some experts believe that an easy-to-take pill can have a substantial impact on the Covid-19 pandemic, potentially leading to fewer SARS-CoV-2–related deaths and alleviating the strain on the U.S. health care system caused by the pandemic. However, William Schaffner, MD, of the Vanderbilt University Medical Center in Nashville, and National Foundation for Infectious Diseases liaison to the CDC’s Advisory Committee on Immunization Practices, told BreakingMED that this pill should not take the focus off of getting vaccines into the arms of as many Americans as possible.
“This pill is not a substitute for the vaccine,” he told BreakingMED. “Benjamin Franklin advised us way back at the founding of our country that an ounce of prevention is worth a pound of cure… There is no substitute for prevention on the front end to avoid having to rely on treatments on the back end. But, nevertheless, we are excited about this drug.”
John McKenna, Associate Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,933,190,926,192,927,151,928,925,934
