Novartis’ Cosentyx (secukinumab) has been approved by the European Commission (EC) to treat adults with active moderate to severe hidradenitis suppurativa (HS).
Cosentyx, which is now the first new treatment option for the inflammatory skin disease in nearly a decade, is specifically indicated for patients who have had an inadequate response to conventional systemic therapy.
There are currently around 200,000 people in Europe living with moderate to severe stages of HS, which causes boil-like abscesses that can burst, creating open wounds and irreversible scarring.
Until now, there has only been 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 – a cytokine involved in inflammation.
Novartis’ application for Cosentyx in HS is supported by 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.
Haseeb Ahmad, president Europe, Novartis, said: “Since its first approval in 2015, Cosentyx has been used to treat more than one million people worldwide. We are pleased to bring Cosentyx as a much needed and trusted treatment option that brings rapid and sustained symptom relief to HS patients.”
“With established market access and patient support programmes, Novartis is in a strong position to support fast and widespread access to Cosentyx,” Ahmad added.
The company has also submitted an application for Cosentyx in this indication to the US Food and Drug Administration, with a decision from the US regulator expected later this year.