Antiviral drug receives authorization from FDA
The U.S. Food and Drug Administration (FDA) today announced that molnupiravir, an investigational oral antiviral drug invented by scientists at Emory University, has received Emergency Use Authorization (EUA) for treatment of COVID-19.
The EUA authorizes the use of molnupiravir for "the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate."
"Molnupiravir was discovered at Emory because of the tremendous vision of George Painter and Dennis Liotta, and the incredible work of so many in our research community," says Gregory L. Fenves, president of Emory University. "Emory's mission is to serve humanity, and throughout this pandemic our faculty, researchers, staff, students, and alumni have stepped up like never before to heal, treat, discover, and share knowledge to save lives. Molnupiravir is yet another example of what Emory can do when we unleash our ambition and expertise on a global challenge to improve life for communities around the world."
"This drug is a direct intervention at a time when this pandemic is not yet over," says George Painter, CEO of Drug Innovation Ventures at Emory (DRIVE) and the director of the Emory Institute for Drug Development (EIDD). "When you look at the daily death toll, and you think that this can help—it doesn't require enormous medical infrastructure to give, can be distributed easily and self-administered—you begin to think about the impact and all that could have. It's overwhelming."
Emory University has discovered and advanced some of the world's most important and valuable drugs such as belatacept for kidney transplants, Obizur for hemophilia, and Emtriva for HIV, successfully taking treatments from bench to bedside. More than 90 percent of HIV patients in the United States take drug combinations that include one of the drugs invented by scientists at Emory.
"Over the years, Emory has invested millions in foundational funding to build a world-class infrastructure to develop early-stage drug candidates for viral diseases of global concern by utilizing the expertise and resources of the university's renowned research enterprise while leveraging industry expertise," says Ravi V. Bellamkonda, provost and executive vice president for academic affairs at Emory University. "In this way, Emory increases the probability that promising drugs will be sufficiently advanced to be licensed by industry and developed for the ultimate benefit of the global community. Molnupiravir represents not just Emory's research innovation, but Emory's innovative mindset and foresight in advancing life-saving drugs in a university setting."
Emory University has been involved in the testing of all three of the vaccines cleared for emergency use in the U.S—Pfizer-BioNTech, Moderna, and Johnson & Johnson (Janssen). The university is still conducting vaccine clinical trials with adults and pediatric populations as well as those related to variants and mix and match boosters. Studies are also ongoing to evaluate new treatments and therapeutics for COVID-19. As the most comprehensive academic health center in Georgia, Emory remains focused on research, drug discovery, and clinical care to improve health outcomes for patients and those it serves.
"Emergency use authorization of molnupiravir is another significant step forward in protecting global public health in the fight against COVID-19," says Dr. Jonathan S. Lewin, executive vice president for health affairs and CEO of Emory Healthcare. "Research conducted at academic medical centers is critical to finding the next scientific discoveries and breakthroughs to improve lives and provide hope now and into the future—I am proud that Emory is part of that future."
The discovery of molnupiravir at Emory was supported in part by funding from the National Institute of Allergy and Infectious Diseases and the Defense Threat Reduction Agency.
"The invention and development through the Investigational New Drug Application (IND) of molnupiravir shows the strength of our system," says Painter. "The federal government funded Emory and we moved the drug quickly into the hands of biotech companies who swiftly guided it through Phase 1— showed proof of principle and then advanced its development."