CHMP backs Cosentyx for adolescents aged 12+ with moderate-to-severe hidradenitis suppurativa
The EMA committee has recommended extending Novartis' IL-17A inhibitor secukinumab to adolescents with HS who responded inadequately to conventional systemic therapy, pending a European Commission decision.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation of Cosentyx (secukinumab) for adolescents aged 12 and older with active moderate-to-severe hidradenitis suppurativa (HS). Novartis announced the opinion on 13 November 2026.
The recommendation covers adolescents who have responded inadequately to conventional systemic HS therapy.
The opinion now goes to the European Commission, which takes the final decision on authorisation. If the Commission approves, Novartis says Cosentyx would be the only IL-17A inhibitor approved for adolescent HS in Europe. It would also be the first new biologic option for this age group in almost ten years.
As general context, a CHMP opinion is a scientific recommendation and does not itself confer a marketing authorisation. The Commission decision typically follows in due course and applies across EU member states.
What it means for your team
- Regulatory teams should track the European Commission decision, which is needed before the adolescent HS indication can be used in the EU.
- Market-access teams should note that Cosentyx could become the only IL-17A inhibitor with an adolescent HS label in Europe, which may shape national reimbursement and pricing discussions.
- Pharmacovigilance and labelling teams should expect product information updates for the adolescent population once the indication is authorised.
Company's press release: Novartis Pharma AG ↗
Article written by VigiEye from the official source (Novartis Pharma AG). Claims are the company's own. AI-assisted; check the source before acting.
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