BioCryst Launches ORLADEYO® (berotralstat) in Ireland
BioCryst Pharmaceuticals (Nasdaq: BCRX) announced that Ireland's Health Services Executive (HSE) has recommended ORLADEYO (berotralstat) for routine prevention of hereditary angioedema (HAE) attacks in patients 12 years and older. This marks the introduction of the first oral, once-daily therapy for HAE attack reduction in Ireland. The recommendation follows the European Commission's marketing authorization granted in April 2021. ORLADEYO is currently licensed in 44 countries.
BioCryst Pharmaceuticals (Nasdaq: BCRX) ha annunciato che il Servizio Sanitario della Irlanda (HSE) ha raccomandato ORLADEYO (berotralstat) per la prevenzione routinaria degli attacchi di angioedema ereditario (HAE) nei pazienti di 12 anni e oltre. Questo segna l'introduzione della prima terapia orale, da assumere una volta al giorno, per la riduzione degli attacchi di HAE in Irlanda. La raccomandazione segue l'autorizzazione all'immissione in commercio concessa dalla Commissione Europea nell'aprile 2021. ORLADEYO è attualmente autorizzato in 44 paesi.
BioCryst Pharmaceuticals (Nasdaq: BCRX) anunció que el Servicio de Salud de Irlanda (HSE) ha recomendado ORLADEYO (berotralstat) para la prevención rutinaria de los ataques de angioedema hereditario (HAE) en pacientes de 12 años en adelante. Esto marca la introducción de la primera terapia oral, que se toma una vez al día, para la reducción de ataques de HAE en Irlanda. La recomendación sigue a la autorización de comercialización otorgada por la Comisión Europea en abril de 2021. ORLADEYO está actualmente autorizado en 44 países.
BioCryst Pharmaceuticals (Nasdaq: BCRX)는 아일랜드의 건강 서비스 집행위원회(HSE)가 12세 이상의 환자에서 유전성 혈관 부종(HAE) 공격의 일상적인 예방을 위해 ORLADEYO (berotralstat)를 추천했다고 발표했습니다. 이는 아일랜드에서 HAE 공격 감소를 위한 최초의 하루 한 번 복용하는 경구 요법의 도입을 의미합니다. 이 권고는 2021년 4월 유럽연합 집행위원회에서 승인된 마케팅 허가에 따른 것입니다. ORLADEYO는 현재 44개 국가에서 허가를 받았습니다.
BioCryst Pharmaceuticals (Nasdaq: BCRX) a annoncé que les Services de Santé d'Irlande (HSE) ont recommandé ORLADEYO (berotralstat) pour la prévention routinière des attaques d'œdème angioneurotique héréditaire (HAE) chez les patients de 12 ans et plus. Cela marque l'introduction de la première thérapie orale, à prendre une fois par jour, pour la réduction des attaques de HAE en Irlande. Cette recommandation fait suite à l'autorisation de mise sur le marché accordée par la Commission Européenne en avril 2021. ORLADEYO est actuellement autorisé dans 44 pays.
BioCryst Pharmaceuticals (Nasdaq: BCRX) gab bekannt, dass der Gesundheitsdienst Irlands (HSE) ORLADEYO (berotralstat) zur routinemäßigen Prävention von Angriffen auf hereditäres Angioödem (HAE) bei Patienten ab 12 Jahren empfohlen hat. Dies markiert die Einführung der ersten oral einzunehmenden Therapie, die einmal täglich zur Reduzierung von HAE-Angriffen in Irland eingenommen wird. Die Empfehlung folgt der von der Europäischen Kommission im April 2021 erteilten Marktzulassung. ORLADEYO ist derzeit in 44 Ländern lizenziert.
- Market expansion with new country approval in Ireland
- First oral, once-daily therapy for HAE in the Irish market
- Product now licensed in 44 countries globally
- None.
Insights
The launch of ORLADEYO in Ireland represents a significant market expansion for BioCryst, though with moderate immediate financial impact given Ireland's population size. The HSE recommendation is particularly noteworthy as it marks another European market penetration following the 2021 EC authorization. With ORLADEYO now licensed in 44 countries, BioCryst continues to execute its global commercialization strategy.
The oral, once-daily administration offers a competitive advantage over existing injectable treatments in the HAE market. This unique positioning should support steady market share gains. While Ireland's HAE patient population is relatively small, this approval strengthens ORLADEYO's position as a leading prophylactic treatment option in Europe and adds another revenue stream to BioCryst's growing international presence.
RESEARCH TRIANGLE PARK, N.C., Nov. 18, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Health Services Executive (HSE) in Ireland has recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older. With this recommendation, HAE patients in Ireland will have access to the first oral, once-daily therapy for the reduction of recurrent HAE attacks.
“The positive HSE recommendation of ORLADEYO broadens access to modern prophylaxis, providing greater choice for prescribing physicians and potentially a better quality of life for HAE patients in Ireland,” said Charlie Gayer, chief commercial officer of BioCryst.
The HSE decision in Ireland follows the European Commission marketing authorization of ORLADEYO in April 2021. To date, ORLADEYO is licensed in 44 countries.
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 the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch/
Please see full Prescribing Information.
The Irish Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) for ORLADEYO (berotralstat) can be found through medicines.ie.
Anyone can report suspected side effects to the HPRA. You can submit a report by visiting the HPRA’s reporting webpage to complete an online form hpra.ie/report. Adverse events should also be reported to BioCryst Pharmaceuticals at medinfoeurope@biocryst.com or +353 1 699 4405.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema 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 BioCryst’s 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 or maintain its commercialization plans for ORLADEYO; 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 sustained market acceptance and demand; the FDA, HSE, 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 projections and forward-looking statements.
BCRXW
Contact:
John Bluth
+1 919 859 7910
jbluth@biocryst.com
Niamh Lyons
+353 87 639 7083
nlyons@biocryst.com
FAQ
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