Cosentyx nod ends 10-year drought in new biologics for HS

Novartis’ IL-17 inhibitor Cosentyx has become the first new biological therapy for the painful skin condition hidradenitis suppurativa (HS) in nearly a decade, following its approval by the European Commission.

Cosentyx (secukinumab) will become a treatment option for the approximately 200,000 people with HS in Europe who are currently living with moderate to severe HS, said the drugmaker in a statement. A decision on the new indication is due later this year in the US.

Cosentyx is already approved to treat psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis and is one of Novartis’ top products, generating $4.8 billion in sales last year.

The approval gives the drug another indication that for the moment has only one other biologic therapy, AbbVie’s TNF inhibitor Humira (adalimumab), and according to Novartis, represents a “sizable” market in its own right.

However, a number of rivals are coming through the pipeline, including IL-17 inhibitors such as UCB’s Bimzelx (bimekizumab) and Acelryn’s izokibep, Boehringer Ingelheim’s IL-36 inhibitor Spevigo (spesolimab) and oral JAK inhibitors from the likes of Pfizer, AbbVie, Incyte and Priovant.

HS is a chronic inflammatory skin disease with limited treatment options that causes symptoms including inflamed nodules or boils in the armpits, groin and genital area. In the phase 3 SUNSHINE and SUNRISE trials, Cosentyx was found to provide a significant reduction in pain and other HS symptoms at 16 weeks that was maintained over a full year.

The full results – recently published in The Lancet – showed that at the primary endpoint more than 70% of patients were flare free and more than 65% had solid pain control, with what Novartis has described as a rapid and lasting improvement in quality of life scores.

“With only one currently approved treatment option, I see HS patients with a tremendous need for alternatives that reduce the disabling physical symptoms of HS, improve the emotional burden and help partially avoid invasive surgery, if treating early,” said Prof Christos Zouboulis, president of the European Hidradenitis Suppurativa Foundation.

“This expanded approval offers physicians an additional effective and, for dermatologists, familiar treatment choice that we can feel confident in prescribing for this complex and challenging disease,” he added.

Novartis is also working on extending the indications for Cosentyx into giant cell arteritis, lupus nephritis, polymyalgia rheumatica and rotator cuff tendinopathy.