医药公司要求FDA扩大SkinJECTTM的使用范围,这是一种微针治疗,在戈林综合征患者中,其病变清除率超过60%. Medicus Pharma seeks FDA expanded access for SKINJECT™, a microneedle therapy showing over 60% lesion clearance in Gorlin Syndrome patients.

医药公司与戈林综合征联盟合作,寻求FDA扩大SKINJECTTM的使用范围,这是用于治疗戈林综合征患者罕见皮肤癌的微针治疗. Medicus Pharma has partnered with the Gorlin Syndrome Alliance to pursue FDA expanded access for SKINJECT™, an investigational microneedle therapy for rare skin cancers in Gorlin Syndrome patients. 在第二阶段试验期临时分析中,该治疗用溶解性微型针来提供 doxorbicin, 显示出超过60%的损伤清除率。 The treatment, using dissolvable microneedles to deliver doxorubicin, showed over 60% lesion clearance in a Phase 2 trial interim analysis. 审判范围扩大到90名美国参与者,并增加了欧洲场地,第二次审判正在阿联酋进行。 The trial expanded to 90 U.S. participants and added European sites, with a second trial ongoing in the UAE. 美国食品和药物管理局的反表明,可能会有505 (b) (2) 批准的途径,患者的意见正在整合到开发中. FDA feedback suggests potential for a 505(b)(2) approval pathway, and patient input is being integrated into development.