Cosentyx Becomes First Biologic Approved For HS In Nearly A Decade

The Swiss major should have a considerable first-to-market advantage over other IL-17 biologics from the likes of UCB and Acelyrin that are also targeting the hidradenitis suppurativa space.

Source: Novartis

There are a number of contenders hoping to get into the hidradenitis suppurativa (HS) market soon but they will have to play catch with Novartis AG's Cosentyx which has just received a green light in the EU for the chronic inflammatory skin disease.

The European Commission has approved Cosentyx (secukinumab) for use in adults with active moderate to severe HS who have had an inadequate response to conventional systemic therapy. The thumbs-up, which comes a couple of months after a positive opinion from the European Medicines Agency, means the interleukin-17A inhibitor, which is already approved for psoriasis, psoriatic arthritis, two types of spondyloarthritis and two childhood arthritic conditions, has become the first new biologic for HS in nearly a decade.

The approval is based on data from the SUNSHINE and SUNRISE Phase III programs which enrolled more than 1,000 patients in 40 countries. The data showed that Cosentyx provided rapid symptom relief from as early as week 4, with response rates continuing to improve up to a year. (Also see "Novartis’s Cosentyx Secures Qualified Win In Hidradenitis Suppurativa" - Scrip, 12 Sep, 2022.)

HS causes recurring boil-like abscesses that can burst, creating open wounds, often in the most intimate parts of the body, resulting in irreversible scarring. Around 200,000 people in Europe currently live with moderate to severe stages of the condition.

Christos Zouboulis, president of the European Hidradenitis Suppurativa Foundation, said: “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.” He added that this latest approval for Cosentyx offered physicians "an additional effective and, for dermatologists, familiar treatment choice that we can feel confident in prescribing for this complex and challenging disease.”

Cosentyx is entering the HS market eight years after AbbVie Inc.'s Humira (adalimumab) got approved for the condition. However, Novartis claimed that around 50% of patients treated with the anti-TNF megablockbuster can lose response.

 More than one million patients have been treated with Cosentyx since its first launch in 2015 and it is "a much needed and trusted treatment option that brings rapid and sustained symptom relief to HS patients,” said Haseeb Ahmad, president of Novartis, Europe. He added that “with established market access and patient support programs," the company was in a strong position to get Cosentyx to patients quickly.

Cosentyx continues to be a major driver of revenues for Novartis but first-quarter sales of the interleukin-17A inhibitor slipped by 7% to $1.28bn. The decline was due in part to the very competitive environment it faces, particularly in psoriasis, but Novartis will be hoping that the European HS approval will help the product return to growth; a regulatory decision from the US Food and Drug Administration is expected later this year.

The HS approval puts Novartis in a strong position to meet its goal of getting approvals in ten indications for Cosentyx. The Basel-headquartered giant is also evaluating the drug for polymyalgia rheumatica, rotator cuff tendinopathy and giant cell arteritis. (Also see "Novartis Targets Ten Indications For Cosentyx " - Scrip, 6 Dec, 2019.)

Novartis is not the only company advancing a biologic that targets IL-17 in a bid to treat the more than 60% of HS patients who remain uncontrolled on Humira and its biosimilars. Two dual IL-17A/IL-17F inhibitors – UCB S.A.'s Bimzelx (bimekizumab; Phase III) and MoonLake Immunotherapeutics AG's sonelokimab (Phase II) – have also impressed in trials, while Acelyrin, Inc.'s IL-17A inhibitor izokibep, licensed from Sweden's Affibody AB, is in Phase IIb/III clinical trials for HS. (Also see "Acelyrin Enters The Spotlight As NASDAQ Debut Dawns" - Scrip, 4 May, 2023.)  (Also see "UCB Aims High In Hidradenitis Suppurativa After Bimzelx Success" - Scrip, 9 Dec, 2022.)