Today, Novartis' innovative biologic Cosentyx®(Secukinumab) has been approved by the National Medical Products Administration for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne inversa). Cosentyx®It is currently the only biologic approved in China for the treatment of Hidradenitis Suppurativa (HS). As a fully human interleukin IL-17A inhibitor, Cosentyx®Can significantly reduce inflammatory nodules and abscesses, controlling the recurrence of the condition.1`, providing a new option for HS treatment`2。
Ian Li, President and Managing Director of Novartis ChinaStated: "The field of immunotherapy is one of Novartis' four core global therapeutic areas. Over the years, we have deeply focused on the two major disease areas of dermatology and rheumatology. This time, Cosentyx...®The approval of the new indication marks the fifth approved use following adult psoriasis, pediatric psoriasis, ankylosing spondylitis, and psoriatic arthritis, further highlighting Cosentyx's®In the field of immunotherapy, Cosentyx holds an important position.®"Since its launch in China, it has benefited more than 500,000 patients. In the future, we will continue to expand the development of new indications, promote standardized diagnosis and treatment, and advance the development of the entire therapeutic field, benefiting a wide range of patients in China."
HS Patients Bear Heavy Disease Burden, More Effective Treatments Needed
HS is a chronic, recurrent, inflammatory skin disease caused by follicular occlusion affecting the follicular sebaceous unit, commonly occurring in areas with apocrine gland distribution such as the axillae, groin, perineum, and perianal region. It mainly presents as painful, deep, inflammatory lesions that begin during puberty, subsequently forming abscesses, sinus tracts, scars, etc., severely impacting the patient's quality of life.3Recurrent boil-like lumps may rupture into open wounds and lead to irreversible scarring, often occurring in intimate areas of the body.4The average time from the onset of symptoms to diagnosis for patients is as long as 10 years.5, 73.6% of patients had progressed to moderate or severe at the time of diagnosis.6。
In China, the prevalence of hidradenitis suppurativa is 33.49 per 100,000 people. It has been included in the "Second National List of Rare Diseases," and currently, about 500,000 patients are severely affected.
Professor Gao Xinghua, Professor of Dermatology at the First Hospital Affiliated to China Medical University, Chairman of the Dermatology and Venereology Branch of the Chinese Medical AssociationSaid: "If HS is not treated in time, it may lead to worsening inflammation, resulting in symptoms such as skin ulceration and pus discharge. In severe cases, sepsis may even occur. The disease burden brought by HS to patients is 'more than skin-deep'. As the condition progresses, the intensity of pain experienced by patients will also increase. Additionally, emotional disorders, such as anxiety (36.2%) and depression (35.8%), are commonly reported comorbidities among HS patients."7"It can be said that HS patients bear a heavy disease burden and great psychological pressure, with strong unmet treatment needs."
Secukinumab Precisely Targets IL-17A, HS Treatment Enters the Biologics Era
Cosentyx®The approval of HS indications is based on the analysis of the largest Phase III research program to date, SUNSHINE and SUNRISE, in which the proportion of patients receiving 300 mg of secukinumab every two or four weeks achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) was higher than that of the placebo.
In the SUNSHINE and SUNRISE studies, the effects of secukinumab were also evaluated at 16 weeks (compared with placebo) and over a 52-week treatment period, with the effects of secukinumab beginning as early as Week 2.8, the efficacy gradually increased up to Week 16 and was continuously observed until Week 52.9。
Professor Wang Baoxi, Chief Doctor of the Dermatology Department at the Plastic Surgery Hospital of the Chinese Academy of Medical Sciences"Patients with HS have significantly higher levels of IL-17A in their serum and lesional skin compared to healthy individuals. Secukinumab treats HS by directly inhibiting interleukin-17A (IL-17A), offering a new treatment option for doctors and HS patients, which helps improve the quality of life for patients. Additionally, the safety profile of secukinumab is consistent with that observed in the treatment of other conditions such as psoriasis."
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Novartis is an innovative pharmaceutical company, with its Chinese name signifying "Commitment to China," meaning improving the health and quality of life of the Chinese people through continuous innovation in products and services. Since 1987, Novartis has had more than 100 innovative drugs and new indications approved in China. For more information, please visit the Novartis Chinese website:http://www.novartis.com.cn。