AJOVOYは片頭痛薬であり,子どもや十代の頭痛が著しく減少し,現在は6-17の症例でFDAに認定されている.
AJOVY, a migraine drug, significantly reduced headaches in kids and teens, and is now FDA-approved for those 6–17.
AJOVOY (フレマネッサブ-vfrm)は,6歳から17歳までの児童・若者の月刊頭痛や頭痛の日を著しく減少させた.
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.
薬剤は,プラセボの2. 5対1. 4で頭痛の日を減少させ (P = 0. 02) 頭痛の日は2. 6対1. 5で (P = 0. 02) 減少させ,AJOVYの47. 2%の患者は,プラセボの27. 0% (P = 0. 002) と比較して,少なくとも50%の頭痛日減少を達成した.
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).
耐性良好で,安全性に関する新たな懸念はなく,現在,少なくとも45kgの重量を持つ小児の片頭痛予防のためにFDAが承認されており,小児および成人の両方の使用に承認された最初のCGRP抗剤となっています.
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.