Novartis’ Cosentyx (secukinumab) has been approved by the US Food and Drug Administration (FDA) to treat adults with moderate-to-severe hidradenitis suppurativa (HS).
The decision makes the IL-17A inhibitor, which is currently approved to treat a range of inflammatory conditions, the first biologic treatment approved for HS in nearly a decade.
An estimated one in 100 people worldwide are affected by HS, a chronic and progressive inflammatory skin disease that 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.
The FDA’s decision was supported by results from two identical late-stage SUNSHINE and SUNRISE trials, in which a higher proportion of patients treated with Cosentyx achieved clinical response compared to those in the placebo group.
Efficacy progressively increased to week 16 and was observed up to week 52, Novartis said, adding that the safety profile of Cosentyx observed in the trials was consistent with its known safety profile observed in plaque psoriasis trials.
Alexa Kimball, lead investigator of the SUNSHINE and SUNRISE trials, said: “For many patients, the daily impact of HS and the search for symptom relief can last years, which can come with painful, irreversible physical and emotional scarring.
“This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option.”
The US approval comes just a few days after Cosentyx was recommended by the National Institute for Health and Care Excellence as a treatment option for adults in England and Wales with active moderate-to-severe HS who have had an inadequate response to conventional systemic HS therapy and where adalimumab is not suitable, did not work or has stopped working.
Novartis said it has an agreement with NHS England to enable eligible HS patients to obtain immediate access to Cosentyx through the interim Innovative Medicines Fund, which provides funding to accelerate NICE-recommended non-cancer medicines into the NHS.
Additionally, the New Treatment Fund in Wales, which ensures faster patient access to medicines recommended by NICE, will enable early access to the drug for eligible patients in Wales.