FDA approval based on robust Phase III data in which Cosentyx® (secukinumab) showed rapid relief from symptoms of hidradenitis suppurativa (HS) as early as Week 21 As the only IL-17A inhibitor approved for HS, Cosentyx offers a meaningful new treatment option that demonstrated reductions in inflammatory nodules and abscesses, and flares2 HS is a chronic, progressive and often painful disease that may affect 1 in 100 people worldwide3,4   Basel, October 31, 2023 — Novartis, a global leader in immuno-dermatology and rheumatology, announced today that the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults.

FDA批准基于强大的III期数据，其中Cosentyx®（secukinumab）早在第21周就显示出化脓性汗腺炎（HS）症状的快速缓解作为唯一批准用于HS的IL-17A抑制剂，Cosentyx提供了一种有意义的新治疗选择，证明炎症性结节和脓肿减少，并且flares2 HS是一种慢性，可能影响全球100人中的1人的进行性和经常痛苦的疾病3,4巴塞尔，2023年10月31日-诺华是免疫皮肤病学和风湿病学的全球领导者，今天宣布美国食品和药物管理局（FDA）已批准Cosentyx®（secukinumab）治疗成人中度至重度化脓性汗腺炎（HS）。

Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine believed to be involved in the inflammation of HS.2 HS is a chronic, systemic and often painful skin disease that causes recurring boil-like lumps that may burst into open wounds and cause irreversible scarring, often in the most intimate parts of the body.3 It may take people living with HS an average of up to 10 years to get a correct diagnosis, which can result in disease progression and significantly impact their quality of life.5,6 Until now, there has been only one biologic approved to treat HS.7 “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,” said Alexa B.

Cosentyx是唯一获得FDA批准的直接抑制白细胞介素-17A（IL-17A）的完全人类生物制剂，IL-17A是一种被认为与HS炎症有关的细胞因子.2 HS是一种慢性，全身性和经常疼痛的皮肤病，可能会爆裂成开放性伤口并导致不可逆的疤痕，通常在身体最亲密的部位.3可能需要HS患者平均长达10年才能得到正确的诊断，这可能导致疾病进展并显着影响他们的生活质量.5,6到目前为止，Alexa B说，只有一种生物制剂被批准用于治疗HS。7“对于许多患者来说，HS的日常影响和寻找症状缓解可能会持续数年，这可能会带来痛苦，不可逆转的身体和情感疤痕。”。

Kimball, MD, MPH, lead investigator of the SUNSHINE and SUNRISE trials, Professor of Dermatology at Harvard Medical School, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston. “This approval marks an important milestone for countless pat.

Kimball，医学博士，公共卫生硕士，阳光和SUNRISE试验首席研究员，哈佛医学院皮肤病学教授，波士顿Beth Israel女执事医疗中心哈佛医学院医师总裁兼首席执行官。“这一批准标志着无数患者的重要里程碑。