BioCryst’s RAPIVAB® (peramivir injection) Receives FDA Approval for a Pediatric Indication
September 21 2017 - 6:00AM
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) a biotechnology
company focused on the development and commercialization of
treatments for rare and infectious diseases, announced today that
the U.S. Food and Drug Administration (FDA) has approved a
supplemental New Drug Application for RAPIVAB (peramivir
injection), an intravenous (i.v.) neuraminidase inhibitor,
extending its availability for the treatment of acute uncomplicated
influenza to pediatric patients 2 years and older who have been
symptomatic for no more than two days. The pediatric approval was
based on the interim analysis of an ongoing pediatric clinical
study. Those results will be presented at the upcoming ID Week 2017
meeting in San Diego.
“This approval represents the first new
influenza antiviral for pediatric use in over 10 years,” said Jon
P. Stonehouse, President & Chief Executive Officer.
“RAPIVAB provides another treatment option for pediatric
patients with acute, uncomplicated influenza and represents another
important milestone for BioCryst.”
“RAPIVAB is a great addition to our
armamentarium of antiviral agents to combat influenza,” said John
A. Vanchiere, MD, PhD, Chief, Section of Pediatric Infectious
Diseases at LSU Health Sciences Center. “It will be
especially helpful for patients who cannot tolerate oral
medications. In addition, the long half-life allows for
one-time dosing which will improve compliance.”
About RAPIVAB (peramivir injection)
Approved by FDA in December 2014, RAPIVAB (peramivir injection)
is an intravenous viral neuraminidase inhibitor approved for the
treatment of acute uncomplicated influenza in patients 2 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 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 or MAA 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; that the Company 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 that 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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