Novartis has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Cosentyx (secukinumab) for use in adults with active moderate to severe hidradenitis suppurativa (HS), a painful and persistent inflammatory skin disease.
CHMP has also recommended a marketing authorisation for Cosentyx, a fully human biologic that directly inhibits interleukin-17A cytokine.
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This recommendation will be forwarded to the European Commission, which is expected to make a final decision within two months.
CHMP’s positive opinion is based on solid results from the Phase III SUNSHINE and SUNRISE identical, global, multicentre, randomised, double-blind, placebo-controlled, parallel-group trials for HS.
The trials assessed the short and long-term efficacy, safety and tolerability of two doses of Cosentyx to treat adults with moderate to severe HS.
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Their primary endpoint was a hidradenitis suppurativa clinical response, defined as a minimum of 50% reduction in abscess and inflammatory nodule (AN) count with no increase in the number of abscesses and/or draining tunnels.
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By GlobalDataSecondary endpoints of the trials were the percentage change from baseline in AN count, the proportion of patients experiencing a flare-up and a skin pain numeric rating scale 30 response after treatment for 16 weeks.
Data from both trials were submitted to the US Food and Drug Administration, which expects to give its decision later this year.
Novartis innovative medicines international president and chief commercial officer Marie-France Tschudin stated: “This positive CHMP opinion brings us one step closer to offering the first new HS treatment in nearly a decade.
“If approved, Cosentyx will provide a much-needed alternative to support the under-served community of approximately 200,000 people with moderate to severe HS in Europe, many of whom are living with painful, uncontrolled symptoms.”
