RESEARCH TRIANGLE PARK, N.C., April 17, 2024 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced today that the Brazilian Health Regulatory Agency (ANVISA) has approved the once-daily oral drug Orladeyo. announced that it had been approved.® (berotralstat) is used to prevent hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age and older.
“Following the positive regulatory decisions we received in Chile and Argentina last year, we are pleased to announce that Olladeyo has been approved in the region’s largest market. This is a significant moment, as a once-daily oral prophylactic therapy will soon be available to help with management. In collaboration with our partner Pint Pharma, ORLADEYO is available in Brazil and throughout Latin America. We look forward to making this happen,” said Charlie Geier, Chief Commercial Officer of BioCryst.
BioCryst is collaborating exclusively with Pint Pharma GmbH to register and promote ORLADEYO in the Pan-Latin American region. Under the terms of the agreement, Pint will be responsible for obtaining and maintaining all marketing permits and commercializing his ORLADEYO in this region.
About Olladeyo® (berotralstat)
Olladeyo® (berotralstat) is the first and only oral therapy specifically designed to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. One capsule per day of ORLADEYO reduces plasma kallikrein activity and prevents HAE attacks.
US indications and important safety information
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Olladeyo® (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.
Usage restrictions
The safety and efficacy of ORLADEYO in the treatment of acute HAE attacks has not been established. ORLADEYO should not be used to treat acute HAE attacks. Additional doses of ORLADEYO or doses greater than 150 mg once daily are not recommended due to the potential for QT prolongation.
Important safety information
Increased QT prolongation was observed at doses higher than the recommended dose of 150 mg once daily and was concentration-dependent.
The most common side effects (≥10%, higher than placebo) in patients receiving ORLADEYO were abdominal pain, vomiting, diarrhea, back pain, and gastroesophageal reflux disease.
A reduced dose of 110 mg PO once daily with a meal is recommended for patients with moderate or severe hepatic impairment (Child-Pugh B or C).
Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. P-gp inducers (e.g., rifampin, St. John's wort) may decrease the plasma concentrations of berotralstat, leading to decreased efficacy of ORLADEYO. The use of P-gp inducers is not recommended with ORLADEYO.
ORLADEYO is a moderate inhibitor of CYP2D6 and CYP3A4 at a dose of 150 mg. Appropriate monitoring and dose titration is recommended for concomitant medications with narrow therapeutic indices that are primarily metabolized by CYP2D6 or CYP3A4. ORLADEYO is a P-gp inhibitor at a dose of 300 mg. Appropriate monitoring and dose titration is recommended for P-gp substrates (e.g., digoxin) when coadministered with ORLADEYO.
The safety and efficacy of ORLADEYO in pediatric patients younger than 12 years has not been established.
There is insufficient data to inform of drug-related risks when using ORLADEYO during pregnancy. There are no data regarding the presence of berotralstat in breast milk, effects on breastfed infants, or effects on milk production.
To report suspected side effects, contact BioCryst Pharmaceuticals, Inc. at 1-833-633-2279 or FDA at 1-800-FDA-1088. www.fda.gov/medwatch.
See full text Prescription information.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals is a global biotechnology company deeply committed to improving the lives of people living with complement-mediated and other rare diseases. BioCryst leverages its expertise in structure-guided drug design to develop first-in-class and best-in-class oral small molecule and protein therapeutics that target difficult-to-treat diseases. BioCryst commercializes his ORLADEYO® (berotralstat) is the first oral, once-daily plasma kallikrein inhibitor and is advancing its pipeline of small molecule and protein therapeutics. For more information, please visit www.biocryst.com or follow us on LinkedIn.
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 and uncertainties that 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. Other possible factors include: These statements reflect the Company's current views regarding future events, 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. Factors that may affect the forward-looking statements contained herein include: The ongoing coronavirus pandemic may pose challenges to all aspects of BioCryst's operations. This includes, but is not limited to, delays, outages, difficulties or increased expenses related to BioCryst's operations. Partner development, regulatory processes, and supply chains that could adversely affect BioCryst's ability to access capital or credit markets to finance its operations or that are described below or in documents that BioCryst periodically files with securities firms. have the effect of increasing many of the risks. Exchange Commission; BioCryst's ability to successfully execute its commercialization plans and commercialize ORLADEYO; This may take longer or be more expensive than planned. The results of BioCryst's partnerships with third parties may not meet BioCryst's current expectations. risks associated with government actions; including the possibility that pricing-related decisions and other actions may not be implemented as expected or at all, or that the results of such decisions and other actions may not be consistent with BioCryst's current expectations; It is included. the commercial viability of ORLADEYO, including its ability to achieve market acceptance; FDA, ANVISA, or other applicable regulatory authorities may require additional studies beyond those planned for the product and product candidates, which may result in delays in planned clinical trials; and may impose certain limitations, warnings, or other requirements on the product. and may impose clinical holds on our product candidates or suspend, delay or withdraw market approval of our products and product candidates. BioCryst's ability to successfully manage its growth and compete effectively; risks associated with the international expansion of BioCryst's operations; In addition, actual financial results may differ from expectations, including that revenues, operating expenses and cash usage may not be within management's expectations. Documents that BioCryst periodically files 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. Please refer to. Actual results could differ materially from those contained in BioCryst's forward-looking statements.
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contact:
john bruce
+1 919 859 7910
jbluth@biocryst.com
