FDA approves Novartis’ Cosentyx for hidradenitis suppurativa treatment

Novartis, a global leader in immuno-dermatology and rheumatology, announced the U.S. Food and Drug Administration’s approval of Cosentyx (secukinumab) for treating adults with moderate to severe hidradenitis suppurativa (HS). This approval places Cosentyx as the only FDA-approved fully human biologic that targets interleukin-17A (IL-17A), a key cytokine involved in HS inflammation.

Understanding Hidradenitis Suppurativa and Its Impact

Hidradenitis suppurativa is recognized as a chronic, painful skin condition, characterized by recurring boil-like lumps leading to open wounds and potential scarring, predominantly affecting intimate body areas. Notably, individuals with hidradenitis suppurativa often experience a prolonged diagnosis period, averaging up to 10 years, exacerbating the disease’s progression and significantly affecting life quality. Cosentyx’s approval marks a pivotal moment in offering new hope to those suffering from this often debilitating condition.

Insights from Clinical Experts and Patients

Echoing the significance of this FDA approval, Dr. Alexa B. Kimball, MD, MPH, lead investigator of the pivotal SUNSHINE and SUNRISE trials and a prominent figure in dermatology, remarked on the lengthy and painful journey of hidradenitis suppurativa patients, emphasizing the profound physical and emotional impacts of the disease. Simultaneously, Donna Atherton, EdD, of the International Association of Hidradenitis Suppurativa Network, shared her personal battles with hidradenitis suppurativa, underscoring the debilitating pain and the profound emotional and social impacts, thereby highlighting the need for effective treatment options.

Efficacy and Safety of Cosentyx in Clinical Trials

The approval of Cosentyx for hidradenitis suppurativa is anchored in findings from the extensive Phase III SUNSHINE and SUNRISE trials, representing the largest hidradenitis suppurativa study cohort to date. These studies revealed that a higher proportion of patients administered with Cosentyx 300 mg biweekly or monthly achieved a significant clinical response compared to those on placebo. Additionally, the safety profile of Cosentyx in these trials aligned with its established safety metrics in plaque psoriasis studies, affirming its differentiated and reliable safety standing.

Cosentyx’s Role in Immuno-Dermatology

Victor Bultó, President of Novartis US, noted Cosentyx’s new indication as its sixth, reiterating Novartis’s commitment to advancing medicine in immunological diseases. This approval not only underscores the efficacy and safety of Cosentyx but also represents a milestone in providing new solutions for challenging dermatological conditions like hidradenitis suppurativa.

Detailed Analysis of the SUNSHINE and SUNRISE Trials

The SUNSHINE and SUNRISE trials, integral to the Cosentyx approval, evaluated the drug’s efficacy and safety over both short-term (16 weeks) and long-term (up to 52 weeks) periods in adults with moderate to severe HS. These studies importantly assessed both primary and secondary outcomes, including the HiSCR50 response rate and impacts on skin pain and disease flares, showcasing the considerable potential of Cosentyx in changing hidradenitis suppurativa treatment paradigms.