ORLADEYO® (berotralstat) Approved in Peru
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced the approval of its drug, ORLADEYO® (berotralstat), by the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru. This oral, once-daily medication is designed for the prevention of hereditary angioedema (HAE) attacks in individuals aged 12 and older. The approval allows BioCryst, in collaboration with Pint Pharma, to provide new treatment options for HAE patients in Peru. This marks another milestone for ORLADEYO, which has already secured approvals in other Latin American countries like Chile, Argentina, Brazil, and Mexico.
- DIGEMID approval for ORLADEYO in Peru, expanding market reach for BioCryst.
- Collaboration with Pint Pharma strengthens BioCryst's presence in Latin America.
- ORLADEYO has prior approvals in Chile, Argentina, Brazil, and Mexico, indicating a strong regulatory track record in the region.
- None.
Insights
BioCryst Pharmaceuticals has received approval from the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru for their drug ORLADEYO® (berotralstat). The drug is used for the prophylaxis of hereditary angioedema (HAE) attacks in patients aged 12 and older. This approval is significant as HAE is a rare but potentially life-threatening condition characterized by recurrent swelling attacks. The oral once-daily administration of ORLADEYO offers a more convenient alternative to the currently available treatments, which are often injected or taken intravenously.
For patients and healthcare providers, this means a potential improvement in compliance and quality of life. The convenience of an oral formulation may lead to better patient adherence to the treatment regimen, thus potentially reducing the frequency and severity of HAE attacks.
From a market perspective, the approval of ORLADEYO in Peru strengthens BioCryst's presence in the pan-Latin America region. Previously approved in Chile, Argentina, Brazil and Mexico, this approval continues the expansion pattern, signifying strong regional adoption. This geographic diversification reduces dependency on any single market and may provide more stable revenue streams.
The partnership with Pint Pharma GmbH is also noteworthy. Pint is responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in Latin America. This collaboration allows BioCryst to leverage Pint's local expertise, potentially accelerating market penetration and uptake.
Financially, the approval in Peru could offer incremental revenue opportunities for BioCryst Pharmaceuticals. While Peru may not represent a large market in isolation, it contributes to the cumulative sales potential in the pan-Latin America region. Investors should note that the company has been strategic in its regional expansion, forming collaborations that minimize the risks and costs associated with entering new markets.
Moreover, the approval aligns with BioCryst's strategy to broaden its global footprint, potentially driving long-term growth. While short-term financial impacts may be limited, the long-term prospects look promising, especially as more countries in Latin America approve the drug.
RESEARCH TRIANGLE PARK, N.C., July 09, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the General Directorate of Medicines, Supplies and Drugs (DIGEMID) in Peru has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.
“We continue to work alongside our partner, Pint Pharma, to bring ORLADEYO to people living with HAE who are in need of new treatment options across the pan-Latin America region. With this decision by DIGEMID, we are excited that patients in Peru will soon be able to benefit from our oral, once-daily prophylactic therapy,” said Charlie Gayer, chief commercial officer of BioCryst.
BioCryst has an exclusive collaboration with Pint Pharma GmbH to register and promote ORLADEYO in the pan-Latin America region. Under the terms of the agreement, Pint is responsible for obtaining and maintaining all marketing authorizations and for commercializing ORLADEYO in LATAM. ORLADEYO has previously been approved in this region by regulatory agencies in Chile, Argentina, Brazil and Mexico.
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
INDICATION
ORLADEYO® (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 use
The 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 (≥
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).
Berotralstat is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein. 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 is a global biotechnology company with a deep commitment 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 or best-in-class oral small-molecule and protein therapeutics to target difficult-to-treat diseases. BioCryst has commercialized ORLADEYO® (berotralstat), the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies. 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, 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: BioCryst’s ability to successfully implement its commercialization plans for ORLADEYO, which could 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 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 FDA, DIGEMID 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; and risks related to the international expansion of BioCryst’s business. 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 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
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