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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 recommended by CHMP for hidradenitis suppurativa

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来源: PMLiVE

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 approved, Cosentyx will be the first new treatment option for the inflammatory skin disease in nearly a decade.

An estimated one in 100 people globally are affected by HS, which causes boil-like abscesses that 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 around half of patients 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 conditions such as psoriatic arthritis and severe plaque psoriasis, Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in inflammation.

The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) is based on results from two identical phase 3 trials, with a combined enrolment of more than 1,000 patients in 40 countries.

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, approximately 50% of Cosentyx-treated patients had a meaningful reduction in HS-related pain at week 52.

Marie-France Tschudin, president of Novartis Innovative Medicines International and chief commercial officer, 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 a much-needed alternative to support the underserved community of approximately 200,000 people with moderate to severe HS in Europe, many of whom are living with painful, uncontrolled symptoms.”

The recommendation will 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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