AJOVY是一种偏头痛的药物,大大降低了儿童和青少年头痛的幅度,现在由食品和药物管理局为6-17岁的人批准。
AJOVY, a migraine drug, significantly reduced headaches in kids and teens, and is now FDA-approved for those 6–17.
根据《新英格兰医学杂志》公布的第三阶段空间试验,AJOVY(fremanezumab-vfrm)显著降低了6至17岁患有偏头痛的儿童和青少年的月偏头痛和头痛日。
AJOVY (fremanezumab-vfrm) significantly reduced monthly migraine and headache days in children and adolescents aged 6 to 17 with episodic migraine, according to the Phase 3 SPACE trial published in the New England Journal of Medicine.
该药物将偏头痛天数减少2.5天,将安慰剂减少1.4天(P=0.02),头痛天数减少2.6天,将1.5天(P=0.02),将AJOVY的病人中47.2%的偏头痛天数至少减少了50%,而安慰剂的偏头痛天数减少27.0%(P=0.002)。
The drug reduced migraine days by 2.5 versus 1.4 with placebo (P = 0.02) and headache days by 2.6 versus 1.5 (P = 0.02), with 47.2% of patients on AJOVY achieving at least a 50% reduction in migraine days compared to 27.0% on placebo (P = 0.002).
它得到良好许可,没有新的安全顾虑,现在经林业发展局批准,在6-17岁至少45公斤的病人中预防儿科偏头痛,使其成为第一个获准供儿科和成人使用的CGRP对抗者。
It was well-tolerated, with no new safety concerns, and is now FDA-approved for pediatric migraine prevention in patients 6–17 who weigh at least 45 kg, making it the first CGRP antagonist approved for both pediatric and adult use.