Apellis Announces U.S. FDA Approval of the EMPAVELI® Injector, a Device to Streamline Self-Administration
WALTHAM, Mass., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI® Injector. The EMPAVELI Injector is 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, M.B. Ch.B., Ph.D., 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, M.D., 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.”
For administration instructions, please see the EMPAVELI Injector Instructions for Use.
About EMPAVELI®/Aspaveli® (pegcetacoplan)
U.S. Important Safety Information for EMPAVELI
BOXED WARNING: SERIOUS INFECTIONS CAUSED BY ENCAPSULATED BACTERIA
WARNINGS AND PRECAUTIONS
Serius Infections Caused by Encapsulated Bacteria
For patients without known history of vaccination, administer required vaccines at least 2 weeks prior to receiving the first dose of EMPAVELI. If immediate therapy with EMPAVELI is indicated, administer required vaccine as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.
Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected. Promptly treat known infections. Serious infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider discontinuation of EMPAVELI in patients who are undergoing treatment for serious infections.
Monitoring PNH Manifestations after Discontinuation of EMPAVELI
Interference with Laboratory Tests
USE IN SPECIFIC POPULATIONS
Females of Reproductive Potential
About Paroxysmal Nocturnal Hemoglobinuria (PNH)
About the Apellis and Sobi Collaboration
Apellis Forward-Looking Statement
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2114f59b-9952-4dcf-835f-c5a0dfc9316b