欧盟正在考虑批准伊丽丽公司的Olumiant治疗严重脱发的青少年, 基于强有力的试验结果.
The EU is considering approval of Eli Lilly’s Olumiant for teens with severe hair loss, based on strong trial results.
欧洲医药署的CHMP建议批准Eli Lilly的Olumiant, 供12至17岁的青少年使用,
The European Medicines Agency’s CHMP has recommended approving Eli Lilly’s Olumiant for adolescents aged 12 to 17 with severe alopecia areata, based on positive Phase 3 trial results showing significant hair regrowth in 42% of patients after 36 weeks.
该药物已被批准用于成人和其他条件,展示了青少年的有利安全特征。
The drug, already approved for adults and other conditions, demonstrated a favorable safety profile in teens.
预计欧盟委员会将在一至两个月内作出决定。
The European Commission is expected to decide within one to two months.
莉莉还计划寻求美国批准这一用途,预计将于2026年底作出决定。
Lilly also plans to seek U.S. approval for this use, with a decision expected in late 2026.