Enable Injections announced today that it received FDA approval for its enFuse injector for the delivery of Empaveli.
Empaveli, commercialized by Apellis Pharmaceuticals, treats adults with paroxysmal nocturnal hemoglobinuria (PNH). The injector — in this case, called the Empaveli Injector — offers self-administration of the pharmaceutical. The compact, wearable device streamlines the self-administration experience with minimal disruption to daily lives.
A targeted C3 therapy, Empaveli regulates excessive activation of the complement cascade within the body’s immune system. This cascade can lead to the onset and progression of many serious diseases.
“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 chair 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.”
enFuse allows hands-free, hidden needle drug delivery of up to 25 mL. Its simple design enables flexibility for at-home self-administration or in-clinic use.
“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 EVP 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.”
Enable Injections featured on our 2021 list of drug delivery innovations you need to know. READ HERE.