On Friday, the U.S. Food and Drug Administration (FDA) approved Novartis AG’s Cosentyx (secukinumab) for younger patients.

The approval covers pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS).

FDA Expands Novartis Cosentyx Label To Pediatric HS Patients

HS is a chronic, systemic inflammatory skin disease that causes recurring boil-like lesions, which can rupture into painful wounds and lead to scarring. 

HS affects as many as 1 in 100 people worldwide and often begins around puberty.

"With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust," said Victor Bultó, President, Novartis US.

"Yet for young people living with moderate to severe hidradenitis suppurativa (HS), treatment options have remained limited for far too long. Expanding Cosentyx to this population addresses a critical gap in care and underscores our focus on advancing solutions where we can make the greatest impact on outcomes."  

Clinical Evidence And Modeling Support Novartis Approval

The approval marks the fourth pediatric indication for Cosentyx, reinforcing its robust safety and efficacy profile.

The studies and pharmacokinetic modeling support the use of Cosentyx in patients aged 12+ with moderate to severe HS weighing 30 kg or more. Researchers extrapolated this modeling from adult HS and psoriasis clinical trials, as well as pediatric clinical trial data from other approved indications.

Dosing analysis also supports the approval and predicts that weight-based dosing of Cosentyx in pediatric patients can provide exposure similar to that in adult HS patients.

NVS Price Action: Novartis ( NVS ) shares were trading higher by 0.96% at $154.92 at the time of publication on Monday, according to Benzinga Pro data.

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