BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today
announced that oral, once-daily ORLADEYO™ (berotralstat)
is now available for shipment to patients with a prescription in
the United States.
ORLADEYO was approved by the U.S. Food and Drug
Administration (FDA) on December 3, 2020 for prophylaxis
to prevent attacks of hereditary angioedema
(HAE) in adults and pediatric patients 12 years and
older. Optime Care, Inc., the exclusive specialty pharmacy
provider for ORLADEYO, has begun shipping to patients today.
“Access to medicine is critical to HAE patients.
Many patients have been waiting for an oral option and I am very
pleased that they have support from BioCryst to access ORLADEYO so
quickly following FDA approval,” said Douglas R. Lotz, M.D., senior
partner, Family Allergy & Asthma, Louisville, KY.
BioCryst is committed to supporting HAE patients
taking ORLADEYO through a new program designed to streamline access
to therapy. Through EMPOWER Patient Services, each HAE patient and
their healthcare provider will have a single point of contact for
access to ORLADEYO. A dedicated care coordinator will support
access for each patient with comprehensive financial support tools
and reimbursement support.
“Our goal is to provide a best-in-class
partnership that enables an individualized approach for physicians
and their patients,” said Charlie Gayer, chief commercial officer
of BioCryst. “Through our dedicated care coordinators, we offer a
single point of contact to assist patients and healthcare providers
throughout the treatment journey. From the transition to ORLADEYO,
coordination of deliveries, to ongoing patient support, EMPOWER
puts the HAE patient at the center.”
Additional information is available
at www.ORLADEYO.com and 1-866-5-EMPOWER
(1-866-536-7693).
About ORLADEYO™ (berotralstat) ORLADEYO™
(berotralstat) is the first and only oral therapy designed
specifically to prevent attacks of hereditary angioedema (HAE) in
adults and pediatric patients 12 years and older. One capsule
of ORLADEYO per day works to prevent HAE attacks by decreasing the
activity of plasma kallikrein.
U.S. Indication and Important Safety
Information
INDICATIONORLADEYO™ (berotralstat) is a
plasma kallikrein inhibitor indicated for prophylaxis to prevent
attacks of hereditary angioedema (HAE) in adults and pediatric
patients 12 years and older.
Limitations of useThe safety
and effectiveness of ORLADEYO for the treatment of acute HAE
attacks have not been established. ORLADEYO should not be used for
the treatment of acute HAE attacks. Additional doses or dosages of
ORLADEYO higher than 150 mg once daily are not recommended due to
the potential for QT prolongation.
IMPORTANT SAFETY INFORMATIONAn
increase in QT prolongation was observed at dosages higher than the
recommended 150 mg once-daily dosage and was concentration
dependent.
The most common adverse reactions (≥10% and
higher than placebo) in patients receiving ORLADEYO were abdominal
pain, vomiting, diarrhea, back pain, and gastroesophageal reflux
disease.
A reduced dosage of 110 mg taken orally once
daily with food is recommended in patients with moderate or severe
hepatic impairment (Child-Pugh B or C) and in patients taking
chronically administered P-glycoprotein (P-gp) or breast cancer
resistance protein (BCRP) inhibitors (eg, cyclosporine).
Berotralstat is a substrate of P-gp and BCRP.
P-gp inducers (eg, rifampin, St. John’s wort) may decrease
berotralstat plasma concentration, leading to reduced efficacy of
ORLADEYO. The use of P-gp inducers is not recommended with
ORLADEYO.
ORLADEYO at a dose of 150 mg is a moderate
inhibitor of CYP2D6 and CYP3A4. For concomitant medications with a
narrow therapeutic index that are predominantly metabolized by
CYP2D6 or CYP3A4, appropriate monitoring and dose titration is
recommended. ORLADEYO at a dose of 300 mg is a P-gp inhibitor.
Appropriate monitoring and dose titration is recommended for P-gp
substrates (eg, digoxin) when coadministering with ORLADEYO.
The safety and effectiveness of ORLADEYO in
pediatric patients <12 years of age have not been
established.
There are insufficient data available to inform
drug-related risks with ORLADEYO use in pregnancy. There are no
data on the presence of berotralstat in human milk, its effects on
the breastfed infant, or its effects on milk production.
To report SUSPECTED ADVERSE REACTIONS,
contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at
1-800-FDA-1088
or www.fda.gov/medwatch.
Please see
full Prescribing
Information.
About BioCryst
Pharmaceuticals
BioCryst 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. Oral, once-daily
ORLADEYO™ (berotralstat) is approved in the United States for the
prevention of HAE attacks in adults and pediatric patients 12 years
and older, and under regulatory review for approval in Japan and
the European Union. BioCryst has several ongoing development
programs including 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 and Korea.
Post-marketing commitments for RAPIVAB are ongoing. 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 BioCryst’s plans and
expectations for ORLADEYO. 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: the ongoing COVID-19 pandemic,
which could create challenges in all aspects
of BioCryst’s business, including without limitation
delays, stoppages, difficulties and increased expenses with respect
to BioCryst’s and its partners’ development,
regulatory processes and supply chains, negatively
impact BioCryst’s ability to access the capital or credit
markets to finance its operations, or have the effect of
heightening many of the risks described below or in the
documents BioCryst files periodically with the
Securities and Exchange Commission; BioCryst’s ability to
successfully implement its commercialization plans for, and to
commercialize, ORLADEYO, which could take longer or be more
expensive than planned; the commercial viability of ORLADEYO,
including its ability to achieve market acceptance; the FDA, EMA,
PMDA or other applicable regulatory agency may require additional
studies beyond the studies planned for product candidates,
including to support the continued commercialization of ORLADEYO,
may not provide regulatory clearances which may result in delay of
planned clinical trials, may impose certain restrictions,
warnings, or other requirements on product
candidates, including ORLADEYO, may impose a clinical hold
with respect to such product candidates, or may withhold
or withdraw market approval for such product
candidates; BioCryst’s ability to successfully manage its
growth and compete effectively; risks related to the international
expansion of BioCryst’s business; and 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
forward-looking statements.
BCRXW
Contact: John
Bluth +1 919 859 7910 jbluth@biocryst.com
Catherine Collier Kyroulis+1 917 886
5586ckyroulis@biocryst.com
A photo accompanying this announcement is
available
at: https://www.globenewswire.com/NewsRoom/AttachmentNg/d19c2ba3-9191-4d58-a615-2cea7d165d48
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