BioCryst Announces RAPIVAB® Pediatric sNDA Acceptance
June 05 2017 - 6:00AM
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that
the U.S. Food and Drug Administration (FDA) has accepted for review
the supplemental New Drug Application (sNDA) for a pediatric
indication of RAPIVAB® (peramivir injection), which was
submitted in March 2017. The sNDA has been classified by the FDA as
a priority review and has a Prescription Drug User Fee Act (PDUFA)
goal date for a decision by the end of September 2017.
"The acceptance of the pediatric sNDA by the FDA
represents another important milestone for BioCryst and our
partner, Seqirus," said Jon P. Stonehouse, President & Chief
Executive Officer. “We are excited the FDA has granted a
priority review with the possibility of making RAPIVAB available to
treat pediatric patients in the next flu season.”
RAPIVAB is being commercialized by Seqirus
globally, excluding Japan, Taiwan, Korea and Israel. Seqirus
is a leader in influenza prevention through the global supply of
seasonal and pandemic influenza vaccines.
About RAPIVAB (peramivir injection)
Approved by FDA in December 2014, RAPIVAB (peramivir injection)
is an intravenous viral neuraminidase inhibitor for the treatment
of acute uncomplicated influenza in patients 18 years and older who
have been symptomatic for no more than two days. Efficacy of
RAPIVAB is based on clinical trials of naturally occurring
influenza in which the predominant influenza infections were
influenza A virus and a limited number of patients infected with
influenza B virus. Visit http://www.rapivab.com to learn more.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and
develops novel small molecule drugs that block key enzymes involved
in rare diseases. BioCryst has several ongoing development
programs: BCX7353 and other second generation oral inhibitors of
plasma kallikrein for hereditary angioedema, and galidesivir, a
broad spectrum viral RNA polymerase inhibitor that is a potential
treatment for filoviruses. RAPIVAB® (peramivir injection), a viral
neuraminidase inhibitor for the treatment of influenza, is
BioCryst's first approved product and has received regulatory
approval in the U.S., Canada, Japan, Taiwan and Korea.
Post-marketing commitment development activities for RAPIVAB are
ongoing, as well as activities to support regulatory approvals in
other territories. For more information, please visit the Company's
website at www.BioCryst.com.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements regarding future results,
performance or achievements. These statements involve known and
unknown risks, uncertainties and other factors which may cause
BioCryst’s actual results, performance or achievements to be
materially different from any future results, performances or
achievements expressed or implied by the forward-looking
statements. These statements reflect our current views with respect
to future events and are based on assumptions and are subject to
risks and uncertainties. Given these uncertainties, you should not
place undue reliance on these forward-looking statements. Some of
the factors that could affect the forward-looking statements
contained herein include: that developing any HAE drug candidate
may take longer or may be more expensive than planned; that ongoing
and future preclinical and clinical development of HAE second
generation drug candidates (including APeX-1 and ZENITH-1) may not
have positive results; that BioCryst may not be able to enroll the
required number of subjects in planned clinical trials of product
candidates; that the Company may not advance human clinical trials
with product candidates as expected; that the FDA may require
additional studies beyond the studies planned for product
candidates, or may not provide regulatory clearances which may
result in delay of planned clinical trials, or may impose a
clinical hold with respect to such product candidate, or withhold
market approval for product candidates (including approval for the
pediatric indication of RAPIVAB); that BioCryst may not receive
additional government funding to further support the development of
galidesivir; that galidesivir development may not be successful;
that BARDA and/or NIAID may further condition, reduce or eliminate
future funding; that revenue from peramivir injection is
unpredictable and may never result in significant revenue for the
Company; that the Company may not be able to continue development
of ongoing and future development programs; that such development
programs may never result in future products; that actual financial
results may not be consistent with expectations, including that
2017 operating expenses and cash usage may not be within
management’s expected ranges. Please refer to the documents
BioCryst files periodically with the Securities and Exchange
Commission, specifically BioCryst’s most recent Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on
Form 8-K, all of which identify important factors that could cause
the actual results to differ materially from those contained in
BioCryst’s projections and forward-looking statements.
BCRXW
CONTACT: Thomas Staab, BioCryst Pharmaceuticals, +1-919-859-7910
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