FILSUVEZ topical gel is indicated for the treatment of partial thickness wounds in patients 6 months and older with Junctional and Dystrophic Epidermolysis Bullosa (EB) FILSUVEZ was well tolerated and met the primary endpoint with statistical significance, with 41.3% of patients achieving first complete target wound closure within 45 days in the Phase 3 clinical trial BOSTON, Dec.

FILSUVEZ局部凝胶适用于治疗6个月及以上患有交界性和营养不良性大疱性表皮松解症（EB）的患者的部分厚度伤口。FILSUVEZ耐受性良好，符合主要终点，具有统计学意义，其中41.3%的患者在3期临床试验波士顿，12月的45天内实现了首次完全目标伤口闭合。

19, 2023 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced today that the U.S. Food and Drug Administration (FDA) approved FILSUVEZ® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB).

2023年19月19日（环球通讯社）--Chiesi Global Rare Diseases是Chiesi Group的一个业务部门，旨在为受罕见疾病影响的人群提供创新疗法和解决方案，今天宣布，美国食品和药物管理局（FDA）批准FILSUVEZ®（桦木三萜）局部凝胶用于治疗6个月及以上的交界性大疱性表皮松解症（JEB）和营养不良性大疱性表皮松解症（DEB）患者的部分厚度伤口。

FILSUVEZ is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy. FILSUVEZ joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year. EB is a debilitating inherited skin disease that causes a person’s skin to be so fragile it can be injured just from touch.

FILSUVEZ是第一个被批准用于治疗与JEB相关的伤口的治疗方法，JEB是一种罕见的中度至重度EB，从婴儿期开始出现水疱。作为今年1月收购Amryt Pharma期间达成的协议的一部分，FILSUVEZ加入了Chiesi投资组合。EB是一种使人衰弱的遗传性皮肤病，它会导致人的皮肤非常脆弱，仅凭触摸就可能受伤。

This rare, chronic, and distressing disorder affects infants, children and adults and is intensely painful; recurrent blistering and chronic wounds can result in intolerable pain with limited mobility. Living with EB entails daily challenges to navigate, including slow-healing wounds at risk of infection and painful dressing changes.

这种罕见的，慢性的，令人痛苦的疾病会影响婴儿，儿童和成人，并且非常痛苦；反复起泡和慢性伤口可导致无法忍受的疼痛，活动受限。与EB一起生活需要每天应对挑战，包括有感染风险的伤口愈合缓慢和痛苦的换药。

FILSUVEZ is administered at home, allowing for integration into existing treatment routines. FILSUVEZ is applied topically to the wound at each dressing change. 'At Chiesi Global Rare Diseases we are dr.

FILSUVEZ在家管理，可以整合到现有的治疗程序中。每次换药时，将FILSUVEZ局部应用于伤口。”在Chiesi Global Rare Diseases，我们是博士。