BEYONTTRA™ (acoramidis), the First Near Complete TTR Stabilizer (≥90%), Approved by the European Commission to Treat ATTR-CM
BridgeBio Pharma (BBIO) has received European Commission approval for BEYONTTRA™ (acoramidis), the first near-complete TTR stabilizer (≥90%) to treat ATTR-CM, a fatal heart condition. The approval is based on the Phase 3 ATTRibute-CM study results, which showed:
- 42% reduction in composite all-cause mortality and recurrent cardiovascular-related hospitalization events at Month 30
- 50% reduction in cumulative frequency of cardiovascular-related hospitalization events at Month 30
- Benefits observed in as few as 3 months
Following the approval, BridgeBio will receive a $75 million milestone payment from Bayer, who will handle EU commercialization. BridgeBio will also receive tiered royalties starting in the low-thirties percent on EU sales. Bayer plans to launch the drug in the first half of 2025. The drug was previously approved in the U.S. as Attruby™ in November 2024, with 430 patient prescriptions written by 248 physicians since approval.
BridgeBio Pharma (BBIO) ha ricevuto l'approvazione della Commissione Europea per BEYONTTRA™ (acoramidis), il primo stabilizzatore di TTR quasi completo (≥90%) per il trattamento dell'ATTR-CM, una condizione cardiaca fatale. L'approvazione si basa sui risultati dello studio di Fase 3 ATTRibute-CM, che ha mostrato:
- Riduzione del 42% della mortalità complessiva e degli eventi di ospedalizzazione cardiovascolare ricorrente al mese 30
- Riduzione del 50% della frequenza cumulativa degli eventi di ospedalizzazione cardiovascolare al mese 30
- Benefici osservati in appena 3 mesi
Dopo l'approvazione, BridgeBio riceverà un pagamento di 75 milioni di dollari come milestone da Bayer, che gestirà la commercializzazione nell'UE. BridgeBio riceverà anche royalties scaglionate a partire dai primi anni del 30% sulle vendite nell'UE. Bayer prevede di lanciare il farmaco nella prima metà del 2025. Il farmaco era stato precedentemente approvato negli Stati Uniti come Attruby™ nel novembre 2024, con 430 prescrizioni scritte da 248 medici da allora.
BridgeBio Pharma (BBIO) ha recibido la aprobación de la Comisión Europea para BEYONTTRA™ (acoramidis), el primer estabilizador de TTR casi completo (≥90%) para tratar el ATTR-CM, una condición cardíaca fatal. La aprobación se basa en los resultados del estudio de Fase 3 ATTRibute-CM, que mostró:
- Reducción del 42% en la mortalidad por todas las causas y en la hospitalización cardiovascular recurrente a los 30 meses
- Reducción del 50% en la frecuencia acumulativa de eventos de hospitalización cardiovascular a los 30 meses
- Beneficios observados en tan solo 3 meses
Tras la aprobación, BridgeBio recibirá un pago por hitos de 75 millones de dólares de Bayer, que se encargará de la comercialización en la UE. BridgeBio también recibirá regalías escalonadas que comenzarán en el bajo trinta por ciento sobre las ventas en la UE. Bayer planea lanzar el medicamento en la primera mitad de 2025. El medicamento fue aprobado previamente en EE. UU. como Attruby™ en noviembre de 2024, con 430 recetas prescritas por 248 médicos desde entonces.
BridgeBio Pharma (BBIO)는 ATTR-CM이라는 치명적인 심장 질환을 치료하기 위한 최초의 거의 완전한 TTR 안정제(≥90%)인 BEYONTTRA™(아코라미디스)에 대해 유럽연합 집행위원회의 승인을 받았습니다. 이 승인은 3상 ATTRibute-CM 연구 결과에 기반하고 있으며, 결과는 다음과 같습니다:
- 30개월 시점에서 모든 원인으로 인한 사망 및 재발하는 심혈관 관련 입원 사건에서 42% 감소
- 30개월 시점에서 심혈관 관련 입원의 누적 빈도에서 50% 감소
- 단 3개월 만에 관찰된 이점
승인 이후, BridgeBio는 Bayer로부터 7500만 달러의 이정표 지급을 받을 예정입니다. Bayer는 EU 상업화를 담당합니다. BridgeBio는 또한 EU 판매에 대해 낮은 30%대에서 시작되는 단계별 로열티를 받을 것입니다. Bayer는 2025년 상반기에 이 약물을 출시할 계획입니다. 이 약물은 2024년 11월에 미국에서 Attruby™로 승인되었으며, 그 이후 248명의 의사에 의해 430개의 환자 처방이 이루어졌습니다.
BridgeBio Pharma (BBIO) a reçu l'approbation de la Commission Européenne pour BEYONTTRA™ (acoramidis), le premier stabilisateur de TTR presque complet (≥90%) pour traiter l'ATTR-CM, une maladie cardiaque mortelle. L'approbation est basée sur les résultats de l'étude de Phase 3 ATTRibute-CM, qui a montré :
- Réduction de 42 % de la mortalité globale et des événements d'hospitalisation cardiovasculaire récurrents au mois 30
- Réduction de 50 % de la fréquence cumulée des événements d'hospitalisation cardiovasculaire au mois 30
- Bénéfices observés en aussi peu que 3 mois
Suite à l'approbation, BridgeBio recevra un paiement de 75 millions de dollars comme jalon de Bayer, qui prendra en charge la commercialisation dans l'UE. BridgeBio recevra également des redevances échelonnées commençant dans les premiers trentaines de pourcentage sur les ventes de l'UE. Bayer prévoit de lancer le médicament au cours de la première moitié de 2025. Le médicament avait été précédemment approuvé aux États-Unis sous le nom d'Attruby™ en novembre 2024, avec 430 prescriptions de patients écrites par 248 médecins depuis l'approbation.
BridgeBio Pharma (BBIO) hat die Genehmigung der Europäischen Kommission für BEYONTTRA™ (Acoramidis) erhalten, den ersten nahezu kompletten TTR-Stabilisator (≥90%) zur Behandlung von ATTR-CM, einer tödlichen Herzkrankheit. Die Genehmigung basiert auf den Ergebnissen der Phase-3-Studie ATTRibute-CM, die Folgendes zeigte:
- 42% Reduktion in der Gesamtsterblichkeit und bei wiederkehrenden kardiovaskulären Krankenhausaufenthalten nach 30 Monaten
- 50% Reduktion in der kumulierten Häufigkeit von kardiovaskulären Krankenhausaufenthalten nach 30 Monaten
- Vorteile, die bereits nach 3 Monaten beobachtet wurden
Nach der Genehmigung wird BridgeBio eine Meilensteinzahlung von 75 Millionen Dollar von Bayer erhalten, der die EU-Kommerzialisierung übernehmen wird. BridgeBio wird auch gestaffelte Lizenzgebühren erhalten, die bei niedrig dreißig Prozent auf den EU-Verkäufen beginnen. Bayer plant, das Medikament in der ersten Hälfte von 2025 auf den Markt zu bringen. Das Medikament wurde zuvor im November 2024 in den USA unter dem Namen Attruby™ genehmigt, wobei seit der Genehmigung 430 Patientenrezepte von 248 Ärzten ausgestellt wurden.
- Received EU marketing authorization for BEYONTTRA™
- Will receive $75 million milestone payment from Bayer
- Entitled to royalties starting in low-thirties percent on EU sales
- Strong U.S. commercial momentum with 430 prescriptions since November 2024
- Phase 3 trial showed 42% reduction in mortality and hospitalization events
- 50% reduction in hospitalization events at Month 30
- None.
Insights
The European Commission's approval of BEYONTTRA™ (acoramidis) marks a pivotal moment for BridgeBio, with multiple significant implications for investors:
Commercial & Financial Strength:
- Immediate financial impact through a
$75 million milestone payment - Attractive royalty structure starting in low-thirties percent indicates strong negotiating position and product value
- Early U.S. launch metrics showing 430 prescriptions from 248 physicians demonstrate robust market adoption
Clinical Differentiation:
- First-in-class ≥90% TTR stabilization label creates a unique market position
- Rapid efficacy demonstrated within 3 months sets new standard in ATTR-CM treatment
42% reduction in mortality and hospitalization events strengthens competitive position
Strategic Partnership Value:
- Bayer's commercial infrastructure and expertise in EU markets maximizes revenue potential
- Multi-regional strategy with pending applications in Japan and Brazil expands global footprint
- Strong execution of the U.S. launch enhances confidence in EU commercialization
The combination of differentiated clinical profile, strong early adoption and strategic partnership with Bayer positions BEYONTTRA™ for significant market penetration in the ATTR-CM space, representing a transformative opportunity for BridgeBio's revenue growth and market position.
- The approval is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date
- In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalization (CVH)) durably separated relative to placebo
- A
42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30 - A
50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30
- Acoramidis is the first and only approved ATTR-CM treatment in the U.S. and EU with a label specifying near-complete stabilization(≥
90% ) - Relative increases in serum TTR concentrations resulting from greater TTR stability have been associated with reduced risk of all-cause and cardiovascular mortality in the general population in recent literature1
- BridgeBio will receive a
$75 million milestone payment from Bayer and will also receive royalties in a tiered structure beginning in the low-thirties percent on sales of BEYONTTRA in the EU
PALO ALTO, Calif., Feb. 11, 2025 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced the European Commission has granted marketing authorization in the European Union (EU) for acoramidis, under the brand name BEYONTTRA™, for the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Acoramidis is a selective small molecule, orally administered near-complete (≥
“ATTR-CM is a rapidly progressing disease with a poor prognosis when left untreated, making the approval of acoramidis, which has demonstrated improved benefit on all-cause mortality and cardiovascular-related hospitalizations in as few as three months, a very important accomplishment for patients. We are pleased that people living with ATTR-CM will have access to another treatment option in the EU,” said Marianna Fontana, M.D., Ph.D., Professor of Cardiology and Honorary Consultant Cardiologist at the National Amyloidosis Centre, Division of Medicine, University College London.
The approval in the EU is based on results of the pivotal ATTRibute-CM Phase 3 study of acoramidis, which showed clear benefits on cardiovascular outcomes. ATTRibute-CM evaluated the efficacy and safety of acoramidis in 632 participants with symptomatic ATTR-CM, associated with either wild-type or variant TTR who were randomized 2:1 to receive acoramidis or placebo for 30 months. The study met its primary clinical endpoints at month 30 by significantly reducing cardiovascular-related hospitalization, improving survival, and preserving functional capacity and quality of life for patients in need.
“The EU approval of acoramidis is a significant advancement for patients living with ATTR-CM in need of new disease-modifying treatments for their condition,” said Dr Jonathan Fox, BridgeBio Cardiorenal Chief Medical Officer. “This approval would not have been possible without the commitment of the clinical trial participants and their families, and the dedicated support of the physicians and scientists involved in the clinical program. Alongside our able partners at Bayer we look forward to this new opportunity to serve ATTR-CM patients across the European Union.”
Following EU approval, Bayer will launch acoramidis in the first half of 2025. Acoramidis was approved as Attruby™ by the U.S. FDA in November 2024 with a label specifying near-complete stabilization of TTR. As reported on January 13, BridgeBio has seen strong commercial momentum, with 430 patient prescriptions written by 248 physicians since the U.S. approval.
In March 2024, BridgeBio and Bayer initiated a collaboration for acoramidis, which granted Bayer exclusive commercialization rights in the EU. Based on terms of the licensing agreement, BridgeBio will receive a
Acoramidis is currently under review for approval by the Japanese Pharmaceuticals and Medical Devices Agency and the Brazilian Health Regulatory Agency .
1Christoffersen M et al. Transthyretin Tetramer Destabilization and Increased Mortality in the General Population. JAMA Cardiol. 2024 Dec 4:e244102.
About BEYONTTRA
BEYONTTRA is an orally administered near-complete (≥
About BridgeBio Pharma, Inc.
BridgeBio Pharma, Inc. (BridgeBio) is a new type of biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn, Twitter and Facebook.
BridgeBio Pharma, Inc. Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements, including statements relating to the impact of BEYONTTRA on clinical outcomes; the potential benefits of BEYONTTRA, including its efficacy and potential to reduce cardiovascular-related hospitalizations, improve survival, and preserve functional capacity and quality of life for patients; and the potential outcomes and expected timing of regulatory reviews and approvals in Japan and Brazil, reflect BridgeBio’s current views about its plans, intentions, expectations, and strategies, which are based on the information currently available to BridgeBio and on assumptions BridgeBio has made. Although BridgeBio believes that its plans, intentions, expectations, and strategies, as reflected in or suggested by these forward-looking statements, are reasonable, BridgeBio can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties, and assumptions, including, but not limited to, the risks associated with BridgeBio’s dependence on third parties for development, manufacture, and commercialization activities related to BEYONTTRA; government and third-party payor actions; risks and uncertainties relating to competitive products and other changes that may limit demand for BEYONTTRA; the risk that regulatory authorities may require additional studies or data to support the continued commercialization of BEYONTTRA; the risk that drug-related adverse events may be observed during commercialization or clinical development; the risk that data and results may not meet regulatory requirements or otherwise be sufficient for further development, regulatory review, or approval; the risk of other regulatory agencies not agreeing with BridgeBio’s regulatory approval strategies, components of BridgeBio’s filings (such as clinical trial designs, conduct, and methodologies), or the sufficiency of data submitted; the continuing success of its collaborations, including compliance with applicable regulations for the purchase, distribution, storage, export, and sale of active pharmaceutical ingredients and medicinal products; uncertainty regarding any impacts due to global health emergencies, including delays in regulatory review, manufacturing, and supply chain interruptions; adverse effects on healthcare systems and disruption of the global economy; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Gaza Strip; and increasing rates of inflation and changing interest rates on BridgeBio’s business operations and expectations. These risks, as well as those set forth in the Risk Factors section of BridgeBio’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and its other filings with the U.S. Securities and Exchange Commission, should be carefully considered. Moreover, BridgeBio operates in a highly competitive and rapidly changing environment, in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of BridgeBio’s management as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
BridgeBio Media Contact:
Bubba Murarka, EVP Communications
contact@bridgebio.com
(650)-789-8220
FAQ
What are the key clinical benefits of BBIO's BEYONTTRA in treating ATTR-CM?
What financial terms did BBIO secure in the Bayer EU commercialization agreement?
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When will BBIO's BEYONTTRA launch in the European Union?
What makes BBIO's BEYONTTRA unique in the ATTR-CM treatment landscape?
