U.S. FDA Grants Fast Track Designation to Novavax’ RSV F Vaccine for Older Adults
May 25 2016 - 8:00AM
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company
focused on the discovery, development and commercialization of
recombinant nanoparticle vaccines and adjuvants, today announced
that the U.S. Food and Drug Administration (FDA) has granted Fast
Track Designation to Novavax’ RSV F-Protein nanoparticle vaccine
candidate (RSV F Vaccine) for the protection of older adults (60
years of age and older).
“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 $28 billion. We fully enrolled
the Resolve™ Phase 3 clinical trial of our RSV F Vaccine in 11,850
older adults in December 2015. The primary efficacy objective of
the Resolve trial is the prevention of moderate-severe
RSV-associated lower respiratory tract disease, as defined by the
presence of multiple lower respiratory tract symptoms.
Gregory M. Glenn, M.D., President, Research and
Development, said, “RSV is a widespread disease that causes
infections of the lower respiratory tract. While RSV affects
individuals of all ages, it acutely impacts older adults and
infants. Our Phase 3 Resolve trial will examine the efficacy of our
RSV F Vaccine and further define the burden of disease in older
adults. We look forward to announcing data from the trial in the
third quarter of this year.”
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.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage
vaccine company committed to delivering novel products to prevent a
broad range of infectious diseases. Our recombinant nanoparticles
and Matrix-M™ adjuvant technology are the foundation for
groundbreaking innovation that improves global health through safe
and effective vaccines. Additional information about Novavax is
available on the Company's website, novavax.com.
References
1. A.R. Falsey et al. Respiratory
syncytial virus infection in elderly and high-risk adults. N Engl J
Med. 2005; 352:1749–59.
2. A.R. Falsey et al. Respiratory
syncytial virus and influenza A infections in the hospitalized
elderly. J. Infect Dis. 1995; 172:389-94.
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.
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Associate Director, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
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