Enable Injections Receives First U.S. Food and Drug Administration (FDA) Approval

The FDA has approved the EMPAVELI Injector (enFuse^®) for the subcutaneous delivery of Apellis’ EMPAVELI^® (pegcetacoplan)

CINCINNATI, September 29, 2023 /PRNewswire/ — Enable Injections, Inc. (“Enable”) today announced that the U.S. Food and Drug Administration (FDA) has approved the  EMPAVELI Injector (enFuse^®) for the subcutaneous delivery of EMPAVELI^® (pegcetacoplan), which is commercialized in the United States by Apellis Pharmaceuticals, Inc. for adults with paroxysmal nocturnal hemoglobinuria (PNH). The EMPAVELI Injector is a compact, wearable injector designed to streamline the self-administration experience with minimal disruption to patients’ daily lives.

“The approval of the EMPAVELI Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy,” said Michael D. Hooven, Enable Injections’ Chairman and CEO. “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.”

“The EMPAVELI Injector is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device,” said Matthew Huddleston, Enable Injections’ Chief Technology Officer and Executive Vice President of Business Development. “The technology was designed while always keeping the patient at the forefront. Its simplicity empowers 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 to enable flexibility for at-home self-administration or in-clinic use.

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