Novartis announced that its interleukin‑17A inhibitor Cosentyx received U.S. Food and Drug Administration approval for treating pediatric patients 12 years and older with moderate to severe hidradenitis suppurativa (HS). The approval expands the drug’s indication beyond its existing adult HS indication and is the first IL‑17A inhibitor approved for this pediatric population.
The approval was based on clinical data from a weight‑based dosing study that enrolled patients aged 12 and older who weighed at least 30 kg. The study demonstrated that Cosentyx was safe and effective, with a favorable benefit‑risk profile that met the FDA’s stringent pediatric criteria. Dosing is tailored to patient weight, allowing clinicians to adjust the 150‑mg or 300‑mg monthly regimen to achieve optimal exposure.
By adding a pediatric indication, Cosentyx now addresses a previously underserved segment of the HS market. Pediatric HS is a chronic, inflammatory skin disease that often emerges around puberty, and treatment options have historically been limited to off‑label use of adult biologics or systemic antibiotics. The new approval positions Cosentyx as the second biologic approved for HS, following AbbVie’s Humira, and gives Novartis a competitive foothold in a niche market with significant unmet need.
The regulatory milestone is expected to broaden Cosentyx’s addressable market and generate additional revenue for Novartis. In the fourth quarter of 2025, Cosentyx sales grew 11 % in constant currency, and in the first quarter of 2025 the drug grew 18 % in constant currency. The pediatric approval is likely to add a new revenue stream that could further accelerate the drug’s growth trajectory, reinforcing Novartis’s dermatology portfolio and supporting the company’s focus on high‑margin innovative medicines.
Novartis has been actively managing its portfolio to strengthen its dermatology focus, including the acquisition of Ziarco and continued investment in biologic development. CEO Vas Narasimhan has emphasized the company’s strategy of pursuing bolt‑on acquisitions to bolster growth beyond 2030. The pediatric HS approval aligns with this strategy by expanding the reach of a proven biologic into a new patient group, potentially enhancing long‑term revenue and market share.
Overall, the FDA approval for Cosentyx in pediatric hidradenitis suppurativa represents a significant regulatory win for Novartis, expanding its product portfolio, addressing an unmet medical need, and positioning the company for continued growth in the dermatology segment.
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