A panel of the European Medicines Agency (EMA) recommended extending Novartis’ Cosentyx to adolescents with hidradenitis suppurativa, a proposed European Union (EU) use that would cover an age group already included in the U.S. label.
The agency’s Committee for Medicinal Products for Human Use (CHMP) adopted its positive opinion Nov. 12. The proposed label would cover people 12 and older whose active HS remains moderate to severe after conventional systemic treatment. The opinion is not final EU authorization; the European Commission must decide on the change.
The EMA meeting agenda says the committee’s review used models to project existing evidence to adolescents. Novartis said its submission combined findings from adult HS studies with pharmacokinetic analyses using adult HS and psoriasis trial data, pediatric data from other Cosentyx uses and weight-based dose analyses. The company said those analyses indicated adolescent drug exposure would generally be in line with levels in adults with HS.
The U.S. Food and Drug Administration’s prescribing information already includes Cosentyx for moderate-to-severe HS in adults and pediatric patients 12 and older. In the EU, the EMA lists Amgevita, an adalimumab biosimilar, for active moderate-to-severe HS in adults and adolescents from age 12. Novartis says approval would make Cosentyx the only IL-17A inhibitor for adolescent HS in Europe, a distinction based on drug class rather than the absence of another biologic option.
MedlinePlus Genetics describes HS as a long-term skin condition involving painful nodules that can rupture, form abscesses and heal with scars. The condition most often emerges after puberty, during adolescence or early adulthood, the resource says.
The EMA says a European Commission decision normally follows 67 days after a CHMP opinion. Novartis expects a decision in about two months, the company said.
