Novartis' Cosentyx wins CHMP backing for hidradenitis suppurativa in adolescents aged 12 and older
NVS•Novartis received a positive European regulatory committee opinion for Cosentyx in adolescents aged 12 and older with moderate to severe hidradenitis suppurativa inadequately controlled by conventional systemic therapy. A European Commission decision is expected within approximately two months.
1. Committee recommendation
The recommendation covers adolescents with active moderate to severe hidradenitis suppurativa whose disease is inadequately controlled by conventional systemic therapy. Existing clinical evidence showed weight-based adolescent dosing provided drug exposure generally comparable to adults, with support from adult trials and pediatric data.
2. Decision expected
A European Commission decision is expected within approximately two months. If cleared, Cosentyx would become Europe's only IL-17A inhibitor for adolescent hidradenitis suppurativa and its first innovative biologic option in nearly a decade.
