Novartis has received approval from the US Food and Drug Administration (FDA) for Cosentyx (secukinumab) for the treatment of paediatric patients aged 12 years and above with moderate to severe hidradenitis suppurativa (HS). The FDA approval expands the therapy’s use to a younger patient population and positions Cosentyx as the first interleukin-17A (IL-17A) inhibitor approved for this group, introducing a biologic treatment option for paediatric patients living with HS.
Hidradenitis suppurativa (HS) is a chronic, systemic inflammatory skin disease characterised by recurring boil-like lesions that may rupture and form painful wounds, often resulting in long-term scarring. Cosentyx works through the IL-17A mechanism, offering physicians a differentiated therapeutic strategy for managing the condition in younger individuals. The therapy’s dosing regimen is tailored based on patient body weight, allowing clinicians to adjust treatment for paediatric patients according to their specific requirements.
The FDA approval covers use in patients aged 12 years and older who weigh at least 30kg. Evidence supporting this decision includes data from studies conducted in adult populations, as well as pharmacokinetic modelling derived from clinical trials involving adult HS and psoriasis. Additional paediatric data from other approved uses also contributed to the evaluation. According to the regulatory submission, dosing analysis indicated that weight-based Cosentyx dosing is expected to achieve similar drug exposure levels in paediatric HS patients as those observed in adults.
Novartis US president Victor Bultó said: “With more than a decade of real-world experience across multiple autoimmune diseases, Cosentyx is a well-established treatment option that many physicians trust.
“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.”
Cosentyx is currently approved for adults with ankylosing spondylitis, HS, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis. In paediatric patients, it is authorised for HS, enthesitis-related arthritis, juvenile psoriatic arthritis, and plaque psoriasis.
