Novartis' Secukinumab Receives FDA Approval as First New Mechanism Therapy in a Decade for Moderate-to-Severe Hidradenitis Suppurativa

On October 31, Novartis announced that the FDA had approved secukinumab (brand name: Cosentyx) for the treatment of adult patients with active moderate to severe hidradenitis suppurativa (HS) who have an inadequate response to conventional systemic HS therapies.Novartis Press Release Shows That Skuchuy‍‍‍‍‍‍‍‍‍‍Youdankang is in the recent decadeThe first novel therapy for Hidradenitis Suppurativa (HS).In June this year, the indication was approved by the EU.

The approval was mainly based on the positive results of the SUNSHINE and SUNRISE studies. SUNSHINE and SUNRISE are two randomized, double-blind, placebo-controlled, multi-center Phase III clinical trials involving 219 sites across 40 countries. Among them, 541 subjects were included in the analysis for SUNSHINE, and 543 subjects were included in the analysis for SUNRISE. The specific treatment regimens are as follows:

Subjects were randomly assigned in a 1:1:1 ratio to receive secukinumab 300 mg every 2 weeks (Q2W group) or every 4 weeks (Q4W group) or placebo (placebo group), with daily topical antibiotics as adjuvant therapy. After the 16-week treatment period, patients in each group could continue treatment until week 52 to assess long-term efficacy. The Q2W and Q4W groups maintained their original dosing regimens, while the placebo group switched to secukinumab 300 mg Q2W or Q4W treatment.

The primary endpoint was the HS response rate at week 16, with response defined as a ≥50% reduction in the number of abscesses and inflammatory nodules, or no increase in the number of abscesses or fistulas compared to baseline.

Results showed that the Q2W groups in both studies met the primary efficacy endpoints. In the SUNSHINE study, the HS response rate in the Q2W group was 45%, significantly higher than the 34% in the placebo group; in the SUNRISE study, the HS response rate in the Q2W group was 42%, also significantly higher than the 31% in the placebo group. In the Q4W group, the HS response rate in the SUNSHINE study was 42%, showing no significant difference compared to the placebo group (34%); in the SUNRISE study, the HS response rate was 46%, significantly higher than the placebo group (31%).

At Week 52, the HS response rate in the Q2W group of the SUNSHINE study increased to 76%, and to 81% in the Q4W group; in the SUNRISE study, the HS response rate in the Q2W group increased to 84%, and to 77% in the Q4W group. In terms of safety, the most common AEs in both trials were headaches. In summary, secukinumab demonstrated a favorable safety profile, consistent with previous reports, with no new safety signals identified.

Secukinumab is the world's first approved fully human interleukin inhibitor, which can specifically neutralize IL-17A from various sources, inhibit its pro-inflammatory effects, and treat multiple autoimmune diseases. It has currently been approved for indications such as psoriatic arthritis and radiographic negative axial spondyloarthritis.

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