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.
梯瓦製藥業（NYSE:TEVA）於週四宣佈，其第三期SPACE研究的頂線結果評估了Ajovy（fremanezumab）在6-17歲的兒童和青少年患者中用於預防間歇性偏頭痛的療效。
The trial met its primary endpoint with Ajovy achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo.
該試驗達到了其主要終點，Ajovy在治療12周後與安慰劑相比，顯著提高了療效。
Also Read: Newly Listed Migraine-Focused AEON Biopharma Stock Plunges On Friday – Read Here Why.
另外閱讀：新上市的偏頭痛專注公司AEON Biopharma股票週五暴跌-點擊此處了解詳情。
Safety data was consistent with that observed in adult populations, with no emergent safety signals.
安全數據與成人群體觀察到的一致，在這個年齡層次偏頭痛患者中沒有出現安全信號。
Full data from the SPACE study will be presented at a medical meeting later this year.
SPACE研究的完整數據將在今年晚些時候的醫學會議上展示。
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，美國FDA批准Ajovy作爲防治成人偏頭痛的首個兩種用法（季度和月度）的抗CGRP（鈣衛蛋白基因相關肽）治療藥物。
"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數據支撐我們的願望，將Ajovy的實證優勢帶到兒童和青少年患者身上，因爲他們的治療選項有限。我很高興看到Ajovy在不同的偏頭痛人群中都持續證明其療效和安全性，包括兒童和青少年患者，” Teva Pharmaceuticals的全球研發執行副總裁兼首席醫學官埃裏克·休斯（Eric Hughes）說。
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數據是CGRP monoclonal antibody（單克隆抗體）在兒童偏頭痛中安全和療效的第一個第三期試驗證據。
The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations.
考慮到兒童和青少年人群中缺乏已獲批使用的預防性偏頭痛治療方法，這些結果具有特殊的重要性。
Migraines are common among children, with an overall estimated prevalence of 7.7%.
兒童中的偏頭痛很常見，總體估計患病率爲7.7%。
The prevalence increases from 5% among children aged 5 to 10 years to approximately 15% among adolescents.
患病率從5%的5-10歲兒童中增加到約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，麻省的一名聯邦法官推翻了以17650萬美元的陪審團裁決結果對禮來（NYSE:LLY）的判決。判決有利於梯瓦製藥，並認爲禮來的偏頭痛藥物Emgality侵犯了與梯瓦的競爭對手Ajovy相關的三項專利。
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）發佈了一份正在進行中間分析的報告，該報告評估了針對慢性或間歇性偏頭痛患者的口服atogepant的長期安全性和耐受性的第3期開放性156周延長研究。
TEVA Price Action: TEVA stock is up 0.49% at $16.46 at last check Thursday.
TEVA股價：上週四最後一次檢查時，TEVA股價以0.49美元的漲幅報收在16.46美元。
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Photo: Andrii Medvediuk via Shutterstock
照片：通過Shutterstock的Andrii Medvediuk
譯文內容由第三人軟體翻譯。