Teva SPACE Pediatric Phase 3 Study Met Its Primary End Point For Efficacy With A Significantly Greater Reduction In Monthly Migraine Days Compared To Placebo; Efficacy Is Consistent With AJOVY Pivotal Phase 3 And Real-World Evidence Studies In Adults...
Teva SPACE Pediatric Phase 3 Study Met Its Primary End Point For Efficacy With A Significantly Greater Reduction In Monthly Migraine Days Compared To Placebo; Efficacy Is Consistent With AJOVY Pivotal Phase 3 And Real-World Evidence Studies In Adults...
Teva SPACE Pediatric Phase 3 Study Met Its Primary End Point For Efficacy With A Significantly Greater Reduction In Monthly Migraine Days Compared To Placebo; Efficacy Is Consistent With AJOVY Pivotal Phase 3 And Real-World Evidence Studies In Adults With No New Emergent Safety Signals Observed
梯瓦製藥太空概念兒科3期研究已達到療效的主要終點，與安慰劑相比，每月偏頭痛天數的顯著減少；療效與成人的AJOVY關鍵3期和真實世界證據研究一致，未觀察到新的新發安全信號。
- SPACE pediatric Phase 3 study met its primary end point for efficacy with a significantly greater reduction in Monthly Migraine Days compared to placebo
- Efficacy is consistent with AJOVY(fremanezumab) pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed
- Full data to be presented at a medical meeting later in 2024
- 太空概念兒科3期研究已達到療效的主要終點，與安慰劑相比，每月偏頭痛天數的顯著減少。
- 療效與成人的AJOVY(fremanezumab)關鍵3期和真實世界證據研究一致，未觀察到新的新發安全信號。
- 完整數據將於2024年晚些時候在醫學會議上展示。
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today positive topline results from its Phase 3 SPACE study evaluating the efficacy of AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. The trial met its primary end point with AJOVY (fremanezumab) achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo. Safety data was consistent with that observed in adult populations, with no emergent safety signals. Full data from the SPACE study will be presented at a medical meeting later this year.
梯瓦製藥工業股份有限公司(NYSE和TASE:TEVA)今天宣佈其SPACE研究的積極頭條結果，評估AJOVY(fremanezumab)用於預防6-17歲的兒童和青少年患者的陣發性偏頭痛的療效。試驗達到了主要終點，與安慰劑相比，在12周的治療中，AJOVY(fremanezumab)的療效顯著優越。安全數據與成人人群觀察到的一致，未觀察到新的新發安全信號。SPACE研究的完整數據將於今年晚些時候在醫學會議上展示。
譯文內容由第三人軟體翻譯。