Novartis’ Cosentyx has gained an early lead in the field of hidradenitis suppurativa (HS), a painful skin condition, potentially giving it an edge over a strong contender, UCB’s bimekizumab.
Novartis recently announced that the FDA has granted approval for Cosentyx (secukinumab) to treat moderate to severe HS in adults. This approval marks a significant milestone, making Cosentyx the first new biologic treatment for this lesser-known skin ailment in nearly a decade.
HS is a distressing skin disease characterized by painful, boil-like abscesses that can develop into open wounds. Until now, only one biologic treatment, AbbVie’s off-patent Humira, has been available for HS patients in the US. The condition is estimated to affect approximately 1 in 100 people globally, but due to limited awareness among non-dermatologists, only about half of HS patients receive a diagnosis, according to dermatologist opinion leaders cited by SVB Securities.
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The FDA’s approval of Cosentyx was based on data from Novartis’ SUNSHINE and SUNRISE studies, demonstrating that Cosentyx effectively reduced lesions in more patients compared to a placebo.
Cosentyx’s approved dosage for HS is 300 mg given every four weeks, with the option for patients to switch to a biweekly dosing schedule if their response is insufficient. Novartis is banking on Cosentyx’s approval for HS, along with potential new indications in giant cell arteritis and lupus nephritis, to drive the medication’s next phase of growth. If all three indications prove successful, Cosentyx could generate an additional $2 billion in peak sales, according to Novartis.
In the third quarter, Cosentyx recorded approximately $1.3 billion in sales, marking a 4% increase over the $1.27 billion generated during the same period in 2022. Over the first nine months of 2023, Cosentyx has accumulated a total of $3.7 billion in revenue.
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While Novartis has secured an advantage in the HS space, it may soon face a formidable rival in UCB’s bimekizumab. Earlier this year, bimekizumab presented data that were described as “incrementally better than” Cosentyx. At the American Academy of Dermatology’s annual meeting, bimekizumab demonstrated significant superiority over a placebo in terms of the proportion of patients achieving at least a 50% reduction in inflammatory lesions.
Despite gaining approval for psoriasis under the name Bimzelx, bimekizumab has faced regulatory challenges. UCB originally anticipated an FDA decision on HS in the third quarter of 2023 but announced in September that the agency’s review was still ongoing without providing further details.
