[6-K] ASTRAZENECA PLC Current Report (Foreign Issuer)
AstraZeneca and Amgen's Tezspire (tezepelumab) received a positive CHMP recommendation for approval in the EU to treat adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The opinion was based on the Phase III WAYPOINT trial, which showed Tezspire reduced nasal polyp size by a mean of 2.08 points and nasal congestion by 1.04 points versus placebo at Week 52, with p<0.001 for both co-primary endpoints.
WAYPOINT data also reported a 98% near-elimination of the need for surgery and an 89% reduction in systemic corticosteroid use versus placebo. Safety and tolerability were consistent with the known profile. Regulatory reviews are ongoing in multiple other countries.
AstraZeneca e Amgen's Tezspire (tezepelumab) ha ricevuto una raccomandazione positiva da parte del CHMP per l'approvazione nell'UE per trattare gli adulti con rinosinusite cronica con polipi nasali (CRSwNP). L'opinione si basa sullo studio di fase III WAYPOINT, che ha mostrato che Tezspire ha ridotto la dimensione dei polipi nasali di una media di 2,08 punti e la congestione nasale di 1,04 punti rispetto al placebo alla settimana 52, con p<0,001 per entrambi gli endpoint co-primari.
I dati WAYPOINT hanno anche riportato una riduzione del 98% della necessità di interventi chirurgici e una riduzione dell'89% dell'uso di corticosteroidi sistemici rispetto al placebo. La sicurezza e la tollerabilità sono state coerenti con il profilo noto. Le revisioni regolatorie sono in corso in vari altri paesi.
AstraZeneca y Amgen han obtenido una recomendación positiva de CHMP para la aprobación en la UE de Tezspire (tezepelumab) para tratar a adultos con rinosinusitis crónica con poliposis nasal (CRSwNP). La opinión se basó en el ensayo de fase III WAYPOINT, que mostró que Tezspire redujo el tamaño de los pólipos nasales en una media de 2,08 puntos y la congestión nasal en 1,04 puntos frente a placebo en la semana 52, con p<0,001 para ambos endpoints co-primarios.
Los datos de WAYPOINT también reportaron una eliminación casi total de la necesidad de cirugía en un 98% y una reducción del uso de corticosteroides sistémicos en un 89% frente al placebo. La seguridad y tolerabilidad fueron consistentes con el perfil conocido. Las revisiones regulatorias siguen en curso en varios otros países.
아스트라제네카와 암젠의 Tezspire(tezepelumab)은 CRSwNP로 불리는 성인용 만성 비강 부비동염 치료를 위한 EU 승인에 대해 긍정적으로 권고되었다. 이 의견은 3상 WAYPOINT 시험에 근거해 Tezspire가 위약 대비 주 52주에 비강 폴립의 크기를 평균 2.08포인트, 비강 충혈을 1.04포인트 감소시켰으며, 두 코-주요 평가항목에서 p<0.001이었다고 밝혔다.
WAYPOINT 데이터는 또한 수술 필요성을 98%까지 거의 제거했고, 위약 대비 전신 코르티코스테로이드 사용을 89% 감소시켰다고 보고했다. 안전성 및 내약성은 알려진 프로필과 일치했다. 여러 다른 국가에서도 규제 심사가 진행 중이다.
AstraZeneca et Amgen's Tezspire (tezepelumab) ont reçu une recommandation positive du CHMP pour une approbation dans l'Union européenne visant à traiter les adultes souffrant de rhinosinusite chronique avec polypose nasale (CRSwNP). L'avis est basé sur l'essai de phase III WAYPOINT, qui a montré que Tezspire réduisait la taille des polypes nasaux de 2,08 points en moyenne et la congestion nasale de 1,04 point par rapport au placebo à la semaine 52, avec p<0,001 pour les deux critères co-primaires.
Les données WAYPOINT ont également montré une éradication quasi-totale du besoin de chirurgie (98%) et une réduction de 89% de l'utilisation de corticostéroïdes systématiques par rapport au placebo. La sécurité et la tolérance étaient conformes au profil connu. Des examens réglementaires sont en cours dans plusieurs autres pays.
AstraZeneca und Amgens Tezspire (Tezepelumab) haben eine positive CHMP-Empfehlung für die Zulassung in der EU zur Behandlung von Erwachsenen mit chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) erhalten. Die Einschätzung basierte auf der Phase-III-Studie WAYPOINT, die zeigte, dass Tezspire die Größe der Nasenpolypen im Mittel um 2,08 Punkte und die Nasenverstopfung um 1,04 Punkte gegenüber Placebo in Woche 52 reduzierte, mit p<0,001 für beide Co-Primärendpunkte.
WAYPOINT-Daten berichteten zudem von einer 98%-igen nahezu Eliminierung des chirurgischen Bedarfs und einer 89%-igen Reduktion der Anwendung von systemischen Kortikosteroiden gegenüber Placebo. Sicherheit und Verträglichkeit entsprachen dem bekannten Profil. Regulatorische Prüfungen laufen in mehreren anderen Ländern.
حصل Tezspire (tezepelumab) التابع لشركتي أسترازينيكا وأمجين على توصية إيجابية من CHMP للموافقة في الاتحاد الأوروبي لعلاج البالغين المصابين بالتهاب الأنف المزمن مع polypnas الأنفية (CRSwNP). تستند الرأي إلى تجربة المرحلة الثالثة WAYPOINT، التي أظهرت أن Tezspire خفض حجم الزوائد الأنفية بمقدار 2.08 نقطة في المتوسط وخفض الاحتقان الأنفي بمقدار 1.04 نقطة مقارنة بالدواء الوهمي عند الأسبوع 52، مع قيمة p<0.001 لكلا الهدفين المشتركين.
كما أظهرت بيانات WAYPOINT انخفاض الحاجة إلى الجراحة بنسبة 98% وتقليل استخدام الكورتيكوستيرويدات الجهازية بنسبة 89% مقارنة بالدواء الوهمي. الأمان والتحمل كانا متسقين مع الملف known. المراجعات التنظيمية جارية في عدة دول أخرى.
阿斯利康与安进的 Tezspire（tezepelumab）已获得欧盟CHMP的积极推荐，用于治疗成人慢性鼻窦炎伴鼻息肉（CRSwNP）。 该意见基于III期WAYPOINT试验，显示 Tezspire 在第52周较安慰剂分别将鼻腔息肉大小平均降低2.08点、鼻塞降低1.04点，且两项共主终点均有 p<0.001 的显著性。
WAYPOINT 数据还报告手术需求几乎消除98%，相比安慰剂全身性皮质类固醇使用减少89%。安全性和耐受性与已知特征一致。监管评审在多个其他国家仍在进行中。
- CHMP positive recommendation for Tezspire in adult CRSwNP based on Phase III WAYPOINT data
- Statistically significant and clinically meaningful decreases in Nasal Polyp Score (-2.08) and Nasal Congestion Score (-1.04) versus placebo at Week 52 (p<0.001)
- Substantial reductions in need for surgery (98%) and systemic corticosteroid use (89%) versus placebo reported in WAYPOINT
- Safety and tolerability consistent with the known profile of tezepelumab
- Established commercial and development collaboration with Amgen, and Tezspire already approved for severe asthma in multiple countries
- None.
Insights
TL;DR: CHMP positive opinion on WAYPOINT results materially advances Tezspire's EU label into CRSwNP, supported by strong efficacy on polyp size and congestion.
The CHMP recommendation is grounded in robust Phase III co-primary endpoint results showing statistically significant and clinically meaningful improvements in Nasal Polyp Score and Nasal Congestion Score at 52 weeks. The magnitude of reductions and the reported near-elimination of surgery and large corticosteroid-use reduction indicate potential to shift treatment pathways for uncontrolled CRSwNP. Safety was consistent with prior data, which supports regulatory acceptability. Ongoing reviews in other jurisdictions could expand global indications if approved.
TL;DR: A positive CHMP opinion positions Tezspire to capture unmet need in CRSwNP and complements its existing severe asthma franchise.
Tezspire already approved and used in severe asthma worldwide, with over 100,000 treated patients cited, and the EU CRSwNP recommendation leverages that established footprint. The reported reductions in surgery and systemic corticosteroid reliance signal potential to reduce healthcare utilization and improve patient quality of life, which can support payer discussions. The collaboration terms with Amgen for shared costs and profit-split have defined commercial mechanics across regions.
AstraZeneca e Amgen's Tezspire (tezepelumab) ha ricevuto una raccomandazione positiva da parte del CHMP per l'approvazione nell'UE per trattare gli adulti con rinosinusite cronica con polipi nasali (CRSwNP). L'opinione si basa sullo studio di fase III WAYPOINT, che ha mostrato che Tezspire ha ridotto la dimensione dei polipi nasali di una media di 2,08 punti e la congestione nasale di 1,04 punti rispetto al placebo alla settimana 52, con p<0,001 per entrambi gli endpoint co-primari.
I dati WAYPOINT hanno anche riportato una riduzione del 98% della necessità di interventi chirurgici e una riduzione dell'89% dell'uso di corticosteroidi sistemici rispetto al placebo. La sicurezza e la tollerabilità sono state coerenti con il profilo noto. Le revisioni regolatorie sono in corso in vari altri paesi.
AstraZeneca y Amgen han obtenido una recomendación positiva de CHMP para la aprobación en la UE de Tezspire (tezepelumab) para tratar a adultos con rinosinusitis crónica con poliposis nasal (CRSwNP). La opinión se basó en el ensayo de fase III WAYPOINT, que mostró que Tezspire redujo el tamaño de los pólipos nasales en una media de 2,08 puntos y la congestión nasal en 1,04 puntos frente a placebo en la semana 52, con p<0,001 para ambos endpoints co-primarios.
Los datos de WAYPOINT también reportaron una eliminación casi total de la necesidad de cirugía en un 98% y una reducción del uso de corticosteroides sistémicos en un 89% frente al placebo. La seguridad y tolerabilidad fueron consistentes con el perfil conocido. Las revisiones regulatorias siguen en curso en varios otros países.
아스트라제네카와 암젠의 Tezspire(tezepelumab)은 CRSwNP로 불리는 성인용 만성 비강 부비동염 치료를 위한 EU 승인에 대해 긍정적으로 권고되었다. 이 의견은 3상 WAYPOINT 시험에 근거해 Tezspire가 위약 대비 주 52주에 비강 폴립의 크기를 평균 2.08포인트, 비강 충혈을 1.04포인트 감소시켰으며, 두 코-주요 평가항목에서 p<0.001이었다고 밝혔다.
WAYPOINT 데이터는 또한 수술 필요성을 98%까지 거의 제거했고, 위약 대비 전신 코르티코스테로이드 사용을 89% 감소시켰다고 보고했다. 안전성 및 내약성은 알려진 프로필과 일치했다. 여러 다른 국가에서도 규제 심사가 진행 중이다.
AstraZeneca et Amgen's Tezspire (tezepelumab) ont reçu une recommandation positive du CHMP pour une approbation dans l'Union européenne visant à traiter les adultes souffrant de rhinosinusite chronique avec polypose nasale (CRSwNP). L'avis est basé sur l'essai de phase III WAYPOINT, qui a montré que Tezspire réduisait la taille des polypes nasaux de 2,08 points en moyenne et la congestion nasale de 1,04 point par rapport au placebo à la semaine 52, avec p<0,001 pour les deux critères co-primaires.
Les données WAYPOINT ont également montré une éradication quasi-totale du besoin de chirurgie (98%) et une réduction de 89% de l'utilisation de corticostéroïdes systématiques par rapport au placebo. La sécurité et la tolérance étaient conformes au profil connu. Des examens réglementaires sont en cours dans plusieurs autres pays.
AstraZeneca und Amgens Tezspire (Tezepelumab) haben eine positive CHMP-Empfehlung für die Zulassung in der EU zur Behandlung von Erwachsenen mit chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) erhalten. Die Einschätzung basierte auf der Phase-III-Studie WAYPOINT, die zeigte, dass Tezspire die Größe der Nasenpolypen im Mittel um 2,08 Punkte und die Nasenverstopfung um 1,04 Punkte gegenüber Placebo in Woche 52 reduzierte, mit p<0,001 für beide Co-Primärendpunkte.
WAYPOINT-Daten berichteten zudem von einer 98%-igen nahezu Eliminierung des chirurgischen Bedarfs und einer 89%-igen Reduktion der Anwendung von systemischen Kortikosteroiden gegenüber Placebo. Sicherheit und Verträglichkeit entsprachen dem bekannten Profil. Regulatorische Prüfungen laufen in mehreren anderen Ländern.
FAQ
What did AstraZeneca report about Tezspire (AZNCF) in this Form 6-K?
What were the key efficacy results from the WAYPOINT trial reported in the filing?
Did the filing report any safety concerns for tezepelumab in CRSwNP?
Are regulatory applications for Tezspire underway in other countries?
How will AstraZeneca and Amgen commercialise Tezspire according to the filing?
