BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced
that the Saudi Food and Drug Authority (SFDA) has approved oral,
once-daily ORLADEYO® (berotralstat) to prevent attacks of
hereditary angioedema (HAE) in adults and pediatric patients 12
years of age and older in Saudi Arabia.
“There is a significant need for new treatment
options for HAE in Saudi Arabia. With this approval, we continue to
deliver on our commitment to bringing our oral, once-daily
prophylactic therapy to as many HAE patients around the world as
possible,” said Charlie Gayer, chief commercial officer of
BioCryst.
In September 2021, BioCryst entered into a
supply and distribution agreement with NewBridge Pharmaceuticals,
which also covers the Gulf Cooperation Council (GCC) and Iraq.
NewBridge Pharmaceuticals, headquartered in Dubai, United Arab
Emirates (UAE), is a regional specialty company with a
comprehensive pharmaceutical platform of services and expertise,
established to bridge the access gap and partner with global pharma
and biotech companies to in-license and commercialize U.S. Food and
Drug Administration or European Medicines Agency approved
innovative therapeutics that address unmet medical needs into the
Middle East and North Africa (MENA) regions.
“This marks the second market in the MENA region
in which ORLADEYO has been approved for patients living with HAE,
building on the approval in the UAE last year. We are pleased with
the decision from the Saudi FDA and we are committed to continuing
our work with BioCryst to bring this important therapy to patients
in the GCC who are in search of a more optimal treatment option to
help manage their HAE,” said Joe Henein, president and chief
executive officer of NewBridge Pharmaceuticals.
ORLADEYO was safe and well tolerated in clinical
trials. The most frequently reported adverse reactions in patients
receiving ORLADEYO compared with placebo were back pain and
gastrointestinal reactions. The gastrointestinal reactions
generally occurred early after initiation of treatment with
ORLADEYO, became less frequent with time and typically
self-resolved.
About
ORLADEYO® (berotralstat)ORLADEYO® (berotralstat)
is the first and only oral therapy designed specifically to prevent
attacks of hereditary angioedema (HAE) in adult 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 and multiple global
markets. BioCryst has several ongoing development programs
including BCX9930, an oral Factor D inhibitor for the treatment of
complement-mediated diseases, BCX9250, an ALK-2 inhibitor for the
treatment of fibrodysplasia ossificans progressiva, and
galidesivir, a potential treatment for Marburg virus disease and
yellow fever. RAPIVAB® (peramivir injection) is approved in the
U.S. and multiple global markets, with post-marketing commitments
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 BioCryst’s plans and expectations for
ORLADEYO. These statements involve known and unknown risks,
uncertainties and other factors which may cause actual results,
performance or achievements to be materially different from any
future results, performance 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; risks
related to government actions, including that decisions and other
actions, including as they relate to pricing, may not be taken when
expected or at all, or that the outcomes of such decisions and
other actions may not be in line with BioCryst’s current
expectations; the commercial viability of ORLADEYO, including its
ability to achieve market acceptance; the results of our
partnership with NewBridge may not meet our current expectations;
the FDA, Saudi FDA, or other applicable regulatory agency may
require additional studies beyond the studies planned for products
and product candidates, may not provide regulatory clearances which
may result in delay of planned clinical trials, may impose certain
restrictions, warnings, or other requirements on products and
product candidates, may impose a clinical hold with respect to
product candidates, or may withhold, delay, or withdraw market
approval for products and 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 revenue, 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, which identify important factors that could
cause the actual results to differ materially from those contained
in BioCryst’s forward-looking statements.
BCRXW
Investor Contact:John Bluth+1
919 859 7910jbluth@biocryst.com
Media Contact:Catherine
Collier Kyroulis+1 917 886 5586ckyroulis@biocryst.com
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