Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval USA - English USA - English
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CINCINNATI, Oct. 2, 2023 ~ Enable Injections, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI Injector (enFuse®) for the subcutaneous delivery of EMPAVELI® (pegcetacoplan). The injector is designed to be used by adults with paroxysmal nocturnal hemoglobinuria (PNH).

Michael D. Hooven, Enable Injections' Chairman and CEO, said that the approval of the EMPAVELI Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy. He added that Enable's purpose is to redefine drug delivery for the benefit of patients and they are looking forward to growing enFuse® partnerships to improve the patient experience around the world.

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Matthew Huddleston, Enable Injections' Chief Technology Officer and Executive Vice President of Business Development, said that this is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device. He added that it was designed with simplicity in mind so as to empower patients to confidently self-administer their therapy at home with greater mobility.

The enFuse® technology allows hands-free, hidden needle drug delivery of up to 25 mL and is designed for simplicity and flexibility for at-home self-administration or in-clinic use.
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