BioCryst Announces Berotralstat Expanded Access Program for Patients with Hereditary Angioedema in United States
June 09 2020 - 4:15PM
BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced that
the company has established an expanded access program (EAP) with
oral, once-daily berotralstat, an investigational drug, for
patients with hereditary angioedema (HAE) in the United States.
Through this program, physicians may be able to
request berotralstat for HAE patients who do not have access to the
product through a clinical trial.
According to the U.S. Food and Drug
Administration (FDA), expanded access is a potential pathway for a
patient with an immediately life-threatening condition or
serious disease or condition to gain access to an investigational
medical product for treatment outside of clinical trials when no
comparable or satisfactory alternative therapy options are
available.
Requests for expanded access to berotralstat
must be made by a U.S. licensed physician. Physicians can request
access for a patient by sending an email to access.us@inceptua.com
or calling 1-888-225-8677.
A new drug application for berotralstat is
currently under review by the FDA with an action date of December
3, 2020 under the Prescription Drug User Fee Act (PDUFA).
About BioCryst
PharmaceuticalsBioCryst Pharmaceuticals discovers novel,
oral, small-molecule medicines that treat rare diseases in which
significant unmet medical needs exist and an enzyme plays a key
role in the biological pathway of the disease. BioCryst has several
ongoing development programs including berotralstat (BCX7353), an
oral treatment for hereditary angioedema, BCX9930, an oral Factor D
inhibitor for the treatment of complement-mediated diseases,
galidesivir, a potential treatment for COVID-19, Marburg virus
disease and Yellow Fever, and BCX9250, an ALK-2 inhibitor for the
treatment of fibrodysplasia ossificans progressiva. 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, Australia,
Japan, Taiwan, Korea and the European Union. Post-marketing
commitments for RAPIVAB are ongoing. For more information, please
visit the Company's website at www.BioCryst.com.
Forward-Looking StatementsThis
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 the
ongoing COVID-19 pandemic could create challenges in all aspects of
our business, including without limitation delays, stoppages,
difficulties and increased expenses with respect to our and our
partners’ development, regulatory processes and supply chains,
could negatively impact our ability to access the capital or credit
markets to finance our operations, or could have the effect of
heightening many of the risks described below or in the documents
we file periodically with the Securities and Exchange Commission;
that developing any HAE product candidate may take longer or may be
more expensive than planned; that ongoing and future preclinical
and clinical development of BCX9930, BCX9250 and galidesivir 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 BioCryst may not advance human clinical
trials with product candidates as expected; that the FDA, EMA, PMDA
or other applicable regulatory agency 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 candidates, or withhold market approval for product
candidates; that actual financial results may not be consistent
with expectations, including that 2020 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:John Bluth+1 919 859
7910jbluth@biocryst.com
BioCryst Pharmaceuticals (NASDAQ:BCRX)
Historical Stock Chart
From Aug 2024 to Sep 2024
BioCryst Pharmaceuticals (NASDAQ:BCRX)
Historical Stock Chart
From Sep 2023 to Sep 2024