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Novartis’ Cosentyx recommended by CHMP for hidradenitis suppurativa

2023-04-27

临床结果临床3期上市批准

Novartis’ Cosentyx (secukinumab) has been recommended by the European Medicines Agency’s human medicines committee to treat adults with active moderate to severe hidradenitis suppurativa (HS).

If approveCosentyxtysecukinumabhe first new treatment option European Medicines Agency disease in nearly a decade.hidradenitis suppurativa (HS)

An estimated Cosentyx00 people globally are affected by HS, which cauinflammatory skin diseasehat can burst, creating open wounds and irreversible scarring. The exact cause of the disease is unknown, but it occurs near hair follicles where there are sweat glands.

Currently, there is only one approved biologic treatment for HS, with aroboil-like abscessess potentially losing response to this.

Surgery is usually considered in advanced cases to remove abscesses and prevent the disease from spreading further, which Novartis describes as an invasive procedure that frequently results in additional scarring.

Currently approved to treat a range of inflammatory conditabscesses as psoriatic arthritis and severe plaque psoriasis, CoNovartiss the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in inflammation.

The positive opinion from the Committeeinflammatoryal Products for Humapsoriatic arthritised on resultplaque psoriasisicCosentyx 3 trials, with a combined enrolment of more than 1,000 patients ininterleukin-17A inflammation

Results showed that Cosentyx continued to improve response rates beyond the primary endpoint analysis at week 16 to more than 55% of patients achieving an HS clinical response measure at week 52.

Additionally, approxCosentyx50% of Cosentyx-treated patients had a meaningful reduction in HS-related pain at week 52.

Marie-France Tschudin, president ofCosentyxs Innovative Medicines International and chief cHS-related painer, said: “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 Novartis Innovative Medicines Internationalderserved community of approximately 200,000 people with moderate to severe HS in Europe, many of whom are living with painful, uncontrolled symptoms.”

The recommendaCosentyxl now be referred to the European Commission, which is expected to deliver a final decision within two months.

The phase 3 results have also been submitted to the US Food and Drug Administration, the company said, with a decision from the US regulator expected later this year.

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