ORLADEYO™ (berotralstat) Data to be Presented at European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congres...
July 01 2021 - 4:15PM
BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced
multiple upcoming data presentations at the European Academy of
Allergy and Clinical Immunology (EAACI) Hybrid Congress from July
10-12, 2021.
- Durable Reduction in Hereditary Angioedema (HAE) Attack Rates
with Berotralstat Over 24 Months: Results from the Phase 3 APeX-2
Study, Oral Session: The Wide New Allergy World, Abstract #170:
Monday, July 12, 2021, 14:15 - 15:45 CET
- Berotralstat Demonstrates Consistently Low Attack Rates in
Adolescent Patients: Subgroup Analysis from APeX-S, ePoster
Discussion: Advances in Urticaria, Angioedema and Skin Allergy,
Abstract #336, Sunday, July 11, 2021, 12:30 -
13:30 CET
- Reduction in On-Demand Medications in Patients with Hereditary
Angioedema (HAE) Treated with Berotralstat, ePoster Discussion:
Advances in urticaria, angioedema and skin allergy, Abstract #250,
Sunday, July 11, 2021, 12:30
- 13:30 CET
ePosters:
- Berotralstat Demonstrates Consistently Low HAE Attack Rates
During COVID-19: Subgroup Analysis from the APeX-S trial, ePoster
Dermatology, Abstract #166
- Berotralstat Reduces Hereditary Angioedema Attack Rates
Regardless of Previous Prophylaxis, ePoster Dermatology, Abstract
#199
- Challenges of Discontinuing Prophylactic Androgens for
Hereditary Angioedema, ePoster Dermatology,
Abstract #210
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
INDICATION
ORLADEYO™ 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 INFORMATION An
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
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. Oral, once-daily
ORLADEYO™ (berotralstat) is approved in the United States, the
European Union, Japan and the United Kingdom for the prevention of
HAE attacks in adults and pediatric patients 12 years and older.
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), a viral
neuraminidase inhibitor for the treatment of influenza, 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 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 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 periodically files 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 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 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
Contact:InvestorsJohn Bluth+1 919
859 7910jbluth@biocryst.com
MediaCatherine Collier
Kyroulis+1 917 886 5586ckyroulis@biocryst.com
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