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美国FDA批准CGRP抑制剂Ubrelvy治疗急性偏头痛

2019-12-24 Allan MedSci原创

美国FDA周一宣布,已批准艾尔建(Allergan)的Ubrelvy(ubrogepant)用于治疗成人急性偏头痛。FDA指出,Ubrelvy并未用于预防偏头痛。Allergan表示,Ubrelvy将于2020年第一季度上市。

美国FDA周一宣布,已批准艾尔建(Allergan)的Ubrelvyubrogepant)用于治疗成人急性偏头痛。FDA指出,Ubrelvy并未用于预防偏头痛。Allergan表示,Ubrelvy将于2020年第一季度上市。

Allergan首席研发官David Nicholson表示:两种剂量的口服给药方案可使治疗更加灵活Allergan指出,Ubrelvy并非麻醉品,没有成瘾性。这项批准得到了ACHIEVE IACHIEVE II试验的支持。在该试验中,有偏头痛史的患者(有或没有先兆)被随机分配接受Ubrelvy或安慰剂治疗。结果显示,Ubrelvy达到了主要终点,该药还可以提供长达24小时的持久缓解。


原始出处:

http://www.firstwordpharma.com/node/1689682#axzz68z4pBXnX

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    2020-11-15 gostraight
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    2020-03-29 jklm09
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    2020-03-18 bugit
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FDA或将批准CGRP抑制剂eptinezumab以预防偏头痛

Alder Bio生物制药公司近日宣布已提交研究性CGRP抑制剂eptinezumab的申请,以获得FDA的批准用于预防偏头痛。该制药商表示,如果得到FDA的批准,eptinezumab可能会在明年第一季度上市。Alder Bio首席执行官Bob Azelby指出,eptinezumab将成为第一个专门用于快速、有效和持续抑制偏头痛的季度输液疗法。

III期临床试验显示:诺华的CGRP抑制剂Aimovig治疗偏头痛展现出长期疗效

诺华的CGRP抑制剂Aimovig(erenumab-aooe)可将每月偏头痛天数减少一半左右。

Lundbeck以近20亿美元收购Alder BioPharmaceuticals,获得CGRP抑制剂eptinezumab的权利

Lundbeck表示,将以每股18.00美元的现金,总价值高达19.5亿美元收购Alder BioPharmaceuticals公司,以获得其两项预防偏头痛实验性疗法的权利,包括CGRP抑制剂eptinezumab和PACAP抑制剂ALD1910。

礼来的CGRP抑制剂Emgality喜获FDA批准,成为阵发性丛集性头痛的治疗药物

美国食品和药物管理局批准将礼来的降钙素基因相关肽(CGRP)抑制剂Emgality(galcanezumab-gnlm),用于治疗成人阵发性丛集性头痛。

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