Novartis' Cosentyx beats UCB drug to finish line as first new biologic for lesser-known skin condition in years

Cosentyx may soon share the hidradenitis suppurativa (HS) field with another inflammatory biologic—but, for now, the Novartis drug has a head start.

That’s good news for the Swiss Pharma, given that dermatology experts predict UCB’s bimekizumab—also angling for an HS nod and recently approved in plaque psoriasis as Bimzelx—to be a strong rival in this disease area.

Late Tuesday, Novartis said the FDA approved Cosentyx (secukinumab) for the treatment of moderate to severe HS in adults. The green light makes Cosentyx the first new biologic to treat the lesser-known skin affliction in nearly a decade, Novartis said in a release.

HS is a painful skin disease for which, until now, only a single biologic treatment was available in the U.S.: AbbVie’s off-patent Humira.

The disease is associated with painful, boil-like abscesses that can turn into open wounds. HS is estimated to affect about 1 in 100 people globally, but, because of relatively low disease awareness among non-dermatologists, only about half of HS patients are diagnosed, a pair of dermatologist opinion leaders wrote in April, as quoted by analysts at SVB Securities.

The FDA approved Cosentyx based on data from Novartis’ late-stage SUNSHINE and SUNRISE studies. In the trials, Cosentyx helped more patients achieve lesion reduction versus placebo.

Cosentyx has been approved for HS as a 300-mg dose given every four weeks. Patients also have the option to transition to a biweekly dosing schedule if their response is inadequate.

Novartis has been banking on Cosentyx’s HS approval, along with potential new indications in giant cell arteritis and lupus nephritis, to drive the med’s next phase of growth. If all three indications are successful, Cosentyx could bring in an additional $2 billion in peak sales, Novartis has said.

In the third quarter, Cosentyx pulled down about $1.3 billion, growing 4% over the $1.27 billion it scored over the same stretch in 2022. For the first nine months of 2023, Cosentyx has generated a total of $3.7 billion.

While Novartis’ approval has given Cosentyx some space to breathe in HS, the drug may soon have a strong rival in UCB’s bimekizumab, which earlier this year posted data that were “incrementally better than” Cosentyx, according to an SVB note from April.

In data shared the American Academy of Dermatology’s annual meeting, bimekizumab significantly topped placebo on the proportion of patients who achieved at least 50% reduction of inflammatory lesions.

Despite recently winning a psoriasis nod as Bimzelx, bimekizumab hasn’t had an easy path to the regulatory finish line. In October, the company noted that now that BIMZELX is approved for psoriasis, it will move forward rapidly to submit applications for additional indications in the U.S.

Editor's note: This story has been updated to reflect the accurate review timing for bimekizumab in HS in the United States.