Enable Injections has received U.S. Food and Drug Administration (FDA) approval of its enFuse injector for subcutaneous delivery of Apellis Pharmaceuticals’ EMPAVELI (pegcetacoplan) to treat adults with paroxysmal nocturnal hemoglobinuria (PNH).

Enable注射剂已获得美国食品和药物管理局（FDA）批准其enFuse注射器，用于皮下递送Apellis Pharmaceuticals的EMPAVELI（pegcetacoplan），以治疗阵发性夜间血红蛋白尿（PNH）的成人。

The injector is compact and wearable, and according to Enable, streamlines self-administration with minimal disruption to patients’ daily lives. enFuse provides hands-free, hidden needle drug delivery of up to 25 mL to create simplicity and enable flexibility.

该注射器紧凑且可穿戴，并且根据Enable的说法，简化了自我管理，对患者日常生活的干扰最小。enFuse提供高达25毫升的免提隐藏针头药物输送，以创建简单性和灵活性。

The approval of the EMPAVELI Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy,' Enable Injections' chairman and CEO Michael D. Hooven told the press. 'Enable's purpose is to redefine drug delivery for the benefit of patients. We are excited about achieving this milestone and are looking forward to growing enFuse partnerships to improve the patient experience around the world.' .

EMPAVELI注射器的批准将增强患者给予大量（20 mL）皮下治疗的经验，“启用注射”主席兼首席执行官Michael D.Hooven向新闻界表示Enable的目的是为了患者的利益重新定义药物输送。我们对实现这一里程碑感到兴奋，并期待着日益增长的enFuse合作伙伴关系，以改善全世界的患者体验。.

'The EMPAVELI Injector is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device,' added Matthew Huddleston, Enable Injections' chief technology officer and executive VP of business development. 'The technology was designed while always keeping the patient at the forefront.

“EMPAVELI注射器是第一个纯粹机械的，大体积的体内皮下给药装置，”Matthew Huddleston补充说，Enable Injections“首席技术官和业务发展执行副总裁”该技术的设计同时始终将患者置于最前沿。

Its simplicity empowers patients to confidently self-administer their therapy at home with greater mobility.' .

它的简单性使患者能够在家中以更大的流动性自信地自我管理他们的治疗。