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news.Novartis has received the US Food and Drug Administration (FDA) approval for Cosentyx (secukinumab) to treat paediatric patients aged 12 years and above with moderate to severe hidradenitis suppurativa (HS).
HS is a chronic inflammatory skin disease causing recurring lesions that can rupture, become painful wounds, and cause scarring. Credit: Yuriy K / Shutterstock.com.
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This marks Cosentyx as the first interleukin-17A (IL-17A) inhibitor approved for this population, offering a new biologic treatment option for paediatric patients with HS.
HS is a chronic, systemic inflammatory skin disease that presents with recurring boil-like lesions, which can rupture, become painful wounds, and lead to scarring.
The IL-17A mechanism of Cosentyx provides a differentiated therapeutic approach to physicians to manage HS in younger patients, and the dosing is tailored according to the weight of the patients.
Use in patients aged 12 years and above with a weight of at least 30kg is supported by studies in adults and pharmacokinetic modelling extrapolated from clinical trials in adult HS and psoriasis, as well as paediatric data from other approved uses.
The FDA approval was further supported by dosing analysis that predicted weight-based Cosentyx dosing would provide similar exposure in paediatric and adult HS patients.
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 approved for adults with ankylosing spondylitis, HS, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis; and in children for HS, enthesitis-related arthritis, juvenile psoriatic arthritis, and plaque psoriasis.
Last month, Novartis signed a research partnership and licensing agreement with Unnatural Products valued at up to $1.7bn to develop macrocyclic peptide therapeutics targeting cardiovascular diseases.
