The FDA approval for the IL-17A inhibitor was based on the findings of a Phase 3 programme, which included the SUNSHINE and SUNRISE clinical trials that featured more than 1,000 patients
FDA approves Novartis’ Cosentyx for the treatment of hidradenitis suppurativa. (Credit: Novartis AG)
Novartis has secured approval from the US Food and Drug Administration (FDA) for Cosentyx (secukinumab) for the treatment of moderate to severe hidradenitis suppurativa (HS) in adult patients.
According to the Swiss pharmaceutical company, Cosentyx is a human biologic that directly suppresses interleukin-17A (IL-17A).
IL-17A is a cytokine suspected to play a role in the inflammation associated with hidradenitis suppurativa, which is a chronic, progressive, and often painful skin condition.
International Association of Hidradenitis Suppurativa Network (IAHSN) founder and chief mission officer Donna Atherton said: “HS is one of the most devastating and exhausting skin diseases. The pain of flares can be debilitating and limits my ability to work or participate in social activities.
“It can have a major impact on me physically and emotionally, including feelings of anxiety, stress and isolation.
“The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease.”
The FDA approval for the IL-17A inhibitor was driven by the findings of a Phase 3 programme, which included the SUNSHINE and SUNRISE studies.
The two trials, put together, featured more than 1,000 patients. They demonstrated that a greater percentage of patients receiving Cosentyx 300mg, whether administered biweekly or monthly, achieved a hidradenitis suppurativa clinical response (HiSCR50) in comparison to those given a placebo.
The FDA approval is for Cosentyx at a 300mg dosage, administered every four weeks, with the option to escalate to every two weeks if the patient’s response is insufficient.
Novartis US president Victor Bultó said: “Cosentyx can offer effective, lasting relief from HS symptoms so that people with HS have a chance to live every day with confidence.
“With this sixth indication approval for Cosentyx – along with ongoing studies in numerous other conditions – we are reaffirming our commitment to reimagine medicine for those living with immunological diseases.”
Cosentyx has previously received approval in the US for ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriatic arthritis (PsA), moderate to severe plaque psoriasis, and two subtypes of juvenile idiopathic arthritis (JIA), which include enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA).