Enable Injections secures FDA approval for Empaveli Injector
03 Oct 2023
Drug Approval
Empaveli Injector is a compact, single-use, on-body device designed to enable the subcutaneous self-administration of Empaveli (pegcetacoplan), a prescription medicine for paroxysmal nocturnal hemoglobinuria (PNH)
Empaveli Injector is a compact, wearable injector. (Credit: PRNewswire/Enable Injections, Inc)
US-based medical technology company Enable Injections has secured the US Food and Drug Administration (FDA) approval for Empaveli Injector (enFuse), based on its enFuse technology.
The Empaveli Injector is a compact, single-use, on-body device designed to enable the subcutaneous self-administration of Empaveli (pegcetacoplan),
Empaveli is a prescription medicine used to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) and is sold in the US by Apellis Pharmaceuticals.
The medical device maker said its enFuse technology will enable hands-free, hidden needle drug delivery of up to 25 mL, and enables at-home self-administration or in-clinic use.
Enable Injections chairman and CEO Michael Hooven said: “The approval of the Empaveli Injector will enhance the patient experience of administering a large volume (20 mL) of subcutaneous therapy.
“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.”
Apellis Pharmaceuticals said the Empaveli Injector is the first high-volume (20mL), subcutaneous on-body delivery system with several advanced features to simplify self-administration.
The compact device offers enhanced mobility to patients during administration, where a push button starts the injection, and a hidden needle automatically retracts upon delivering the dose.
Enable’s enFuse syringe transfer system offers a wide range of flexible delivery options, including viscosities, volumes, delivery times, and sites for administration.
In addition, the technology allows in-clinic or outside-clinic administration by a healthcare provider and at-home self-administration by the patient.
Apellis Pharmaceuticals rare disease advisor head Peter Hillmensaid said: “Empaveli continues to demonstrate its potential to elevate the standard of care, including rapid and sustained improvements of PNH disease measures.
“Now, we are further enhancing the patient experience with the approval of the Empaveli Injector, an innovative and first-of-its-kind, high-volume injector.”
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