Teva's Migraine Treatment Found Effective For Children As Young As 6
Teva's Migraine Treatment Found Effective For Children As Young As 6
Teva Pharmaceutical Industries Ltd (NYSE:TEVA) announced on Thursday 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.
梯瓦制药业（NYSE:TEVA）于周四宣布，其第三期SPACE研究的顶线结果评估了Ajovy（fremanezumab）在6-17岁的儿童和青少年患者中用于预防间歇性偏头痛的疗效。
The trial met its primary endpoint with Ajovy achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo.
该试验达到了其主要终点，Ajovy在治疗12周后与安慰剂相比，显著提高了疗效。
Also Read: Newly Listed Migraine-Focused AEON Biopharma Stock Plunges On Friday – Read Here Why.
另外阅读：新上市的偏头痛专注公司AEON Biopharma股票周五暴跌-点击此处了解详情。
Safety data was consistent with that observed in adult populations, with no emergent safety signals.
安全数据与成人群体观察到的一致，在这个年龄层次偏头痛患者中没有出现安全信号。
Full data from the SPACE study will be presented at a medical meeting later this year.
SPACE研究的完整数据将在今年晚些时候的医学会议上展示。
In September 2018, the FDA approved Ajovy as the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults.
2018年9月，美国FDA批准Ajovy作为防治成人偏头痛的首个两种用法（季度和月度）的抗CGRP（钙卫蛋白基因相关肽）治疗药物。
"The SPACE data supports our ambitions to bring the proven benefits of Ajovy to children and adolescent patients who have fewer treatment options available to them. I am pleased to see that Ajovy is continuing to demonstrate its efficacy and safety in different migraine populations, including pediatric patients," said Eric Hughes, executive vice president, Global R&D and chief medical officer, at Teva Pharmaceuticals.
“SPACE数据支撑我们的愿望，将Ajovy的实证优势带到儿童和青少年患者身上，因为他们的治疗选项有限。我很高兴看到Ajovy在不同的偏头痛人群中都持续证明其疗效和安全性，包括儿童和青少年患者，” Teva Pharmaceuticals的全球研发执行副总裁兼首席医学官埃里克·休斯（Eric Hughes）说。
The SPACE data are the first Phase 3 trial evidence of safety and efficacy of an anti-CGRP monoclonal antibody for migraine in a pediatric population.
SPACE数据是CGRP monoclonal antibody（单克隆抗体）在儿童偏头痛中安全和疗效的第一个第三期试验证据。
The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations.
考虑到儿童和青少年人群中缺乏已获批使用的预防性偏头痛治疗方法，这些结果具有特殊的重要性。
Migraines are common among children, with an overall estimated prevalence of 7.7%.
儿童中的偏头痛很常见，总体估计患病率为7.7%。
The prevalence increases from 5% among children aged 5 to 10 years to approximately 15% among adolescents.
患病率从5%的5-10岁儿童中增加到约15%的青少年中。
Last year, a federal judge in Massachusetts overturned a $176.5 million jury verdict against Eli Lilly And Co (NYSE:LLY). The verdict favored Teva Pharmaceutical and found that Lilly's migraine drug, Emgality, infringed upon three patents related to Teva's rival drug, Ajovy.
去年，麻省的一名联邦法官推翻了以17650万美元的陪审团裁决结果对礼来（NYSE:LLY）的判决。判决有利于梯瓦制药，并认为礼来的偏头痛药物Emgality侵犯了与梯瓦的竞争对手Ajovy相关的三项专利。
In April, AbbVie Inc (NYSE: ABBV) released an interim analysis of an ongoing Phase 3, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine.
今年4月，AbbVie公司（NYSE:ABBV）发布了一份正在进行中间分析的报告，该报告评估了针对慢性或间歇性偏头痛患者的口服atogepant的长期安全性和耐受性的第3期开放性156周延长研究。
TEVA Price Action: TEVA stock is up 0.49% at $16.46 at last check Thursday.
TEVA股价：上周四最后一次检查时，TEVA股价以0.49美元的涨幅报收在16.46美元。
- Novartis' Q2 Earnings: Revenue And EPS Beat, Raises 2024 Profit Forecast On Strong Demand For Key Drugs.
- 诺华第二季度财报:营收和每股收益都超过预期，基于主要药物的需求上调了2024年利润预测。
Photo: Andrii Medvediuk via Shutterstock
照片：通过Shutterstock的Andrii Medvediuk