Novartis wins EU panel support for teenage use of Cosentyx in skin disease
A European regulatory committee has backed secukinumab for adolescents with moderate-to-severe hidradenitis suppurativa, potentially giving Novartis an edge among IL-17A inhibitors in this younger group.
Novartis has cleared a key European hurdle in extending Cosentyx (secukinumab) to younger patients. The company said on 13 November 2026 that the European Medicines Agency's human-medicines committee, the CHMP, issued a positive opinion for use in adolescents aged 12 and over with active moderate-to-severe hidradenitis suppurativa (HS).
The recommendation applies to adolescents whose disease has not responded adequately to conventional systemic therapy. Novartis has not disclosed any sales expectations for the new group in the information available, so the revenue effect cannot yet be sized.
The commercial argument rests on positioning. If the European Commission follows the committee, Novartis says Cosentyx would be the only IL-17A inhibitor approved for adolescent HS in Europe. The company also describes it as the first new biologic option for this age group in almost ten years.
The opinion is a scientific recommendation, not an authorisation. As general context, the Commission takes the binding decision, and an approval applies across EU member states. Until that decision is issued, the adolescent indication cannot be used in the EU.
Why it matters
- Novartis could hold a differentiated position as the sole IL-17A inhibitor labelled for adolescent HS in Europe, if the Commission approves.
- The CHMP opinion is not an authorisation; the European Commission decision is still needed before the indication can be used.
- A distinct adolescent label may feature in national reimbursement and pricing discussions, though no pricing details have been disclosed.
- Product information and pharmacovigilance materials will need updating for the adolescent population once the indication is authorised.
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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