Apellis Announces US FDA Approval of the EMPAVELI Injector, a Device to Streamline Self-Administration
Apellis Pharmaceuticals, Inc. recently announced the US FDA has approved the EMPAVELI Injector, a compact, single-use, on-body device designed to enhance self-administration of EMPAVELI (pegcetacoplan), which is approved for adults with paroxysmal nocturnal hemoglobinuria (PNH).
“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,” said Peter Hillmen, MB ChB, PhD, Head, Rare Disease Advisor, Apellis. “This approval is an example of how we are continually innovating with patients at the forefront.”
The EMPAVELI Injector is the first high-volume (20mL), subcutaneous on-body delivery system which features several advances to streamline self-administration. The compact device offers patients greater mobility when administering EMPAVELI. A push button starts the injection, and the hidden needle automatically retracts upon dose completion. The EMPAVELI Injector is developed in collaboration with Enable Injections, based on the enFuse Syringe Transfer System.
“The approval of the EMPAVELI Injector is an exciting advancement. People living with PNH can now receive the benefits of EMPAVELI via on-body treatment administration, allowing for greater mobility,” said Carlos de Castro, MD, Professor of Medicine, Duke University. “With the EMPAVELI Injector, patients can seamlessly integrate EMPAVELI treatment into their daily lives, whether that is at home or on the go.”
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases. For more information, visit http://apellis.com. For administration instructions, please see the EMPAVELI Injector Instructions for Use.
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