U.S. FDA Grants Fast Track Designation to Novavax’ RSV F Vaccine for Older Adults
“The FDA’s granting of Fast Track designation for our RSV F Vaccine in older adults underscores its recognition of RSV as a significant unmet medical need in this large population segment,” said Stanley C. Erck, President and CEO. “This joins our prior Fast Track designation for the RSV F Vaccine for the protection of infants via maternal immunization. Fast Track designation could allow for an expedited timeline to licensure, accelerating the access to this vaccine for the most vulnerable populations.”
It is estimated that 16,000 older adults die of RSV infection or its complications annually in the U.S., with approximately 900,000 medical interventions for a total economic burden of disease of approximately
The Fast Track Drug Development Program was established under the FDA Modernization Act of 1997 and is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Specifically, Fast Track designation facilitates meetings to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a Biologics License Application (BLA) on a rolling basis as data become available, which permits the FDA to review modules of the BLA as they are received instead of waiting for the entire BLA submission. Finally, priority review (6 month review versus standard 10 month review) is a potential benefit that may be available to Novavax' RSV F Vaccine in the future.
3. K. Widmer et al. Rates of hospitalizations for respiratory syncytial virus, human metapneumovirus, and influenza virus in older adults. J Infect Dis. 2012; 206: 56-62.
4. K. Widmer et al. Respiratory syncytial virus & human metapneumovirus-associated emergency department and hospital burden in adults. Influenza and Other Respiratory Viruses. 2014; 8(3): 347-352.
Novavax, Inc. Barclay A. PhillipsSVP, Chief Financial Officer and Treasurer Andrea N. Flynn, Ph.D. Associate Director, Investor Relations firstname.lastname@example.org 240-268-2000 Russo Partners, LLC David Schull Todd Davenport, Ph.D. email@example.com firstname.lastname@example.org 212-845-4271