BioCryst Receives Health Canada Approval for RAPIVAB® for the Treatment of Influenza
January 08 2017 - 3:30PM
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX), a pharmaceutical
company focused on the development and commercialization of
treatments for rare diseases, today announced that Health Canada
has approved RAPIVAB
® (peramivir injection), an
intravenous (I.V.) treatment for acute, uncomplicated
influenza.
RAPIVAB is approved by the U.S. Food & Drug
Administration (FDA) and is also licensed for use in Japan and
Taiwan as RAPIACTA® and in Korea as PeramiFlu®.
“This RAPIVAB approval represents an important
milestone for BioCryst and for our partner, Seqirus,” said Jon P.
Stonehouse, President & Chief Executive Officer. “We are
excited that patients in Canada will soon have an I.V. option for
the treatment of influenza infections.”
RAPIVAB is being commercialized by Seqirus
globally, excluding Japan, Taiwan, Korea and Israel. Seqirus
is a leader in influenza prevention through the supply of seasonal
and pandemic influenza vaccine to global markets.
About RAPIVAB (peramivir
injection)
RAPIVAB (peramivir injection) is an intravenous
(I.V.) 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; a
limited number of subjects infected with influenza B virus were
enrolled. The efficacy of RAPIVAB could not be established in
patients with serious influenza requiring hospitalization. In
clinical studies, side effects with RAPIVAB were similar to
placebo. The most common adverse reaction was diarrhea (RAPIVAB 8%
vs 7% placebo). Similar to other neuraminidase inhibitors, there is
a risk of neuropsychiatric events (confusion, delirium) and serious
skin reactions. Visit www.rapivab.com to learn more.
In January 2010, Shionogi & Co., Ltd.
launched intravenous peramivir in Japan under the name RAPIACTA®,
and subsequently launched RAPIACTA in Taiwan. In August 2010, Green
Cross Corporation announced that it had received marketing and
manufacturing authorization for I.V. peramivir in Korea under the
name PeramiFlu®.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and
develops novel small molecule drugs that block key enzymes involved
in rare diseases. BioCryst currently has several ongoing
development programs: BCX7353 and second generation oral inhibitors
of plasma kallikrein for hereditary angioedema, and galidesivir,
(formerly BCX4430), 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 is currently
marketed in the U.S., Japan, Taiwan and Korea. Post-marketing
commitment development activities 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 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 Health Canada may not provide regulatory
approval for any use of RAPIVAB for certain patient populations or
that the approval may be limited. 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: Robert Bennett, BioCryst Pharmaceuticals, +1-919-859-7910
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