Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU)
Novartis has announced the presentation of data from 17 abstracts at the 2025 AAAAI-WAO Joint Congress and AAD Annual Meeting, showcasing its immunology portfolio developments. The presentations will feature:
- Two-year efficacy and safety analyses from Phase III SUNSHINE and SUNRISE trials of Cosentyx® (secukinumab) for hidradenitis suppurativa (HS)
- New 52-week data analyses from Phase III REMIX pivotal trials of investigational remibrutinib for chronic spontaneous urticaria (CSU), demonstrating improvements in urticaria control, sleep, and activity
The company plans to submit regulatory filings for remibrutinib as a CSU treatment in the first half of 2025. Additionally, remibrutinib is being investigated for other immune-mediated conditions, including chronic inducible urticaria, HS, and food allergy.
Novartis ha annunciato la presentazione di dati provenienti da 17 abstract al Congresso Congiunto AAAAI-WAO 2025 e all'Incontro Annuale AAD, mostrando gli sviluppi del suo portafoglio in immunologia. Le presentazioni includeranno:
- Analisi di efficacia e sicurezza a due anni dai trial di Fase III SUNSHINE e SUNRISE di Cosentyx® (secukinumab) per l'hidradenite suppurativa (HS)
- Nuove analisi di dati a 52 settimane dai trial pivotal di Fase III REMIX dell'investigativo remibrutinib per l'orticaria spontanea cronica (CSU), dimostrando miglioramenti nel controllo dell'orticaria, nel sonno e nell'attività
L'azienda prevede di presentare domande regolatorie per il remibrutinib come trattamento per la CSU nella prima metà del 2025. Inoltre, il remibrutinib è in fase di studio per altre condizioni mediate dal sistema immunitario, tra cui l'orticaria cronica inducibile, l'HS e le allergie alimentari.
Novartis ha anunciado la presentación de datos de 17 resúmenes en el Congreso Conjunto AAAAI-WAO 2025 y en la Reunión Anual de la AAD, mostrando los desarrollos de su cartera de inmunología. Las presentaciones incluirán:
- Análisis de eficacia y seguridad a dos años de los ensayos de Fase III SUNSHINE y SUNRISE de Cosentyx® (secukinumab) para la hidradenitis supurativa (HS)
- Nuevos análisis de datos a 52 semanas de los ensayos pivotal de Fase III REMIX del investigacional remibrutinib para la urticaria espontánea crónica (CSU), demostrando mejoras en el control de la urticaria, el sueño y la actividad
La empresa planea presentar solicitudes regulatorias para el remibrutinib como tratamiento para la CSU en la primera mitad de 2025. Además, se está investigando el remibrutinib para otras condiciones mediadas por el sistema inmunológico, incluyendo la urticaria inducible crónica, la HS y las alergias alimentarias.
노바르티스는 2025 AAAAI-WAO 공동 회의 및 AAD 연례 회의에서 면역학 포트폴리오 개발을 보여주는 17개의 초록 데이터 발표를 발표했습니다. 발표 내용은 다음과 같습니다:
- Cosentyx® (세쿠키누맙)를 위한 2년간의 효능 및 안전성 분석, SUNSHINE 및 SUNRISE 시험의 3상 연구 결과
- 만성 자발성 두드러기(CSU)를 위한 임상 시험 REMIX의 52주 데이터 분석, 두드러기 조절, 수면 및 활동에서의 개선을 보여줍니다.
회사는 2025년 상반기 내에 CSU 치료를 위한 remibrutinib의 규제 제출을 계획하고 있습니다. 또한, remibrutinib은 만성 유도성 두드러기, HS 및 식품 알레르기 등 다른 면역 매개 질환에 대해서도 연구되고 있습니다.
Novartis a annoncé la présentation de données provenant de 17 résumés lors du Congrès Commun AAAAI-WAO 2025 et de la Réunion Annuelle de l'AAD, mettant en avant les développements de son portefeuille en immunologie. Les présentations comprendront :
- Des analyses d'efficacité et de sécurité sur deux ans des essais de Phase III SUNSHINE et SUNRISE de Cosentyx® (secukinumab) pour l'hidradénite suppurative (HS)
- De nouvelles analyses de données à 52 semaines des essais pivot de Phase III REMIX du remibrutinib expérimental pour l'urticaire spontanée chronique (CSU), montrant des améliorations dans le contrôle de l'urticaire, le sommeil et l'activité
L'entreprise prévoit de soumettre des demandes réglementaires pour le remibrutinib en tant que traitement de la CSU au cours du premier semestre 2025. De plus, le remibrutinib est à l'étude pour d'autres conditions médiées par le système immunitaire, y compris l'urticaire induisible chronique, le HS et les allergies alimentaires.
Novartis hat die Präsentation von Daten aus 17 Abstracts beim 2025 AAAAI-WAO Joint Congress und der AAD Jahresversammlung angekündigt, die die Entwicklungen seines Immunologie-Portfolios zeigen. Die Präsentationen werden Folgendes umfassen:
- Zwei-Jahres-Effektivitäts- und Sicherheitsanalysen aus den Phase-III-Studien SUNSHINE und SUNRISE von Cosentyx® (Secukinumab) zur Hidradenitis suppurativa (HS)
- Neue 52-Wochen-Datenanalysen aus den Phase-III REMIX entscheidenden Studien zu dem experimentellen Remibrutinib bei chronischer spontaner Urtikaria (CSU), die Verbesserungen bei der Kontrolle der Urtikaria, dem Schlaf und der Aktivität zeigen
Das Unternehmen plant, im ersten Halbjahr 2025 regulatorische Anträge für Remibrutinib als CSU-Behandlung einzureichen. Darüber hinaus wird Remibrutinib auch für andere immunvermittelte Erkrankungen untersucht, darunter chronische induzierbare Urtikaria, HS und Nahrungsmittelallergien.
- Pipeline advancement with remibrutinib regulatory submission planned for 1H 2025
- Positive long-term data from multiple Phase III trials
- Portfolio expansion into multiple immune-mediated conditions
- None.
Insights
Novartis's data presentations at upcoming medical conferences highlight significant long-term clinical evidence for two key immunology assets. The two-year efficacy and safety data from SUNSHINE and SUNRISE trials for Cosentyx in hidradenitis suppurativa (HS) could strengthen its market position in this challenging inflammatory skin condition. More compelling is the 52-week data from the Phase III REMIX trials for remibrutinib in chronic spontaneous urticaria (CSU), demonstrating sustained impact across multiple clinical endpoints.
What's particularly noteworthy is Novartis's confirmation of regulatory submission timelines for remibrutinib in CSU, with filings on track for first half of 2025. This oral BTK inhibitor represents a potential paradigm shift for CSU patients who remain symptomatic on antihistamines - a substantial unmet need. The pipeline expansion of remibrutinib beyond CSU into chronic inducible urticaria, HS, and food allergy demonstrates strategic portfolio deepening within immunology.
These developments position Novartis to potentially address significant treatment gaps in dermatological and allergic conditions that severely impact quality of life. The breadth of data (17 abstracts) suggests robust clinical evidence that could support adoption and reimbursement following potential approval.
Novartis's clinical data presentations highlight meaningful progress for two strategic immunology assets. The remibrutinib program deserves particular investor attention, as its regulatory submissions for CSU in 1H 2025 represent a near-term catalyst. As an oral BTK inhibitor, remibrutinib could significantly disrupt the CSU treatment landscape currently dominated by injectable biologics.
The expansion of remibrutinib's development into multiple immune-mediated conditions (CSU, chronic inducible urticaria, HS, and food allergy) demonstrates Novartis's strategy to maximize the commercial potential of this asset through indication expansion. This approach creates multiple shots on goal from a single molecule, enhancing the overall value proposition.
For Cosentyx, the two-year data in HS builds on its already established presence across multiple immunological conditions. This continued development helps defend and potentially grow its $4+ billion franchise against biosimilar competition expected in key markets later this decade.
These developments align with Novartis's broader strategic pivot toward innovative medicines following the Sandoz spin-off. The immunology therapeutic area represents a high-growth, high-margin opportunity where Novartis is establishing a differentiated portfolio beyond its traditional oncology strength. With multiple catalysts ahead, including the remibrutinib regulatory submissions, these programs merit close monitoring for their potential to drive medium-term growth.
- Two-year efficacy and safety data analyses from Phase III SUNSHINE and SUNRISE trials of continuous Cosentyx® (secukinumab) treatment in HS to be presented
- New analyses of 52-week data from Phase III REMIX pivotal trials of investigational remibrutinib, demonstrating impact in key clinical outcomes for patients with CSU also to be presented
- Regulatory submissions for remibrutinib as a treatment for CSU on track for filing in 1H 2025
Data presented at the congresses include long-term urticaria control, sleep, and activity analyses from the Phase III REMIX-1 and REMIX-2 studies evaluating investigational remibrutinib for the treatment of chronic spontaneous urticaria (CSU). Additionally, long-term data from the Cosentyx® (secukinumab) Phase III SUNSHINE and SUNRISE trials in patients with hidradenitis suppurativa (HS) and patient-reported outcomes from a Phase II trial evaluating remibrutinib in HS will be presented.
"Conditions like CSU and HS are more than just skin deep, often having a profound impact on patients' daily lives and activities," said Angelika Jahreis, Global Head, Development, Immunology, Novartis. "These data at AAAAI and AAD highlight our continued commitment to reimagine medicine and address treatment gaps for people with immune-mediated diseases. We are particularly excited about the potential for remibrutinib as a novel oral treatment for patients with CSU who remain symptomatic on antihistamines."
These CSU data will support regulatory submissions in the first half of 2025. In addition to CSU, remibrutinib is being investigated in other immune-mediated conditions, including chronic inducible urticaria (CIndU), HS, and food allergy.
Key abstracts accepted by AAAAI include:
Abstract Title | Abstract Number/ |
Remibrutinib | |
The Impact of Remibrutinib on Urticaria Control in Patients with Chronic Spontaneous Urticaria: Long-term Results from the REMIX-1/-2 Phase 3 Trials | Abstract #598 |
Remibrutinib Treatment Has No Clinical Impact on Mean Blood Cell Counts in Patients With Chronic Spontaneous Urticaria: Pooled | Abstract #592 |
Key abstracts accepted by AAD include:
Abstract Title | Abstract Number/ |
Remibrutinib | |
Effect of Remibrutinib on Sleep and Daily Activities in Patients With Chronic Spontaneous Urticaria (CSU) up to Week 52 in the REMIX-1/-2 studies | Abstract #62278 |
Improvements in Itch and Hive Symptoms With Remibrutinib as Early as Week 1 in Patients With Chronic Spontaneous Urticaria (CSU) in REMIX-1/-2 | Abstract #P62280 |
Effects of Remibrutinib Treatment on Ambulatory Blood Pressure in Adult Patients With Chronic Spontaneous Urticaria (CSU) | Abstract #62284 |
Remibrutinib in patients with moderate to severe hidradenitis suppurativa: Patient reported outcomes from a randomized, phase 2, double-blind, placebo-controlled platform study | Abstract #62279 |
Cosentyx | |
The impact of continuous secukinumab treatment between weeks 52–104 on draining tunnels in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial | Abstract #63334 |
The impact of continuous secukinumab treatment between weeks 52–104 on HiSCR75, HiSCR90, and HiSCR100 in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial | Abstract #62149 |
Efficacy of secukinumab uptitration from every 4 weeks to every 2 weeks dosing between weeks 52-104 in week 52 HiSCR non-responder patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE extension trial | Abstract #63451 |
The impact of continuous secukinumab treatment through week 104 on efficacy outcomes in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE core and extension trials | Abstract #64857 |
The impact of continuous secukinumab treatment through week 104 on patient reported outcomes in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the SUNSHINE and SUNRISE core and extension trials | Abstract #64674 |
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