Enable Injections Earns CE Mark for enFuse with Aspaveli

Enable Injections has announced CE certification of its enFuse on-body injector and syringe transfer system for use with Aspaveli (pegcetacoplan).

The European Commission fist approved Aspaveli for paroxysmal nocturnal hemoglobinuria (PNH) in December 2021. It became the first treatment for primary IC-MPGN and first treatment for C3G and primary IC-MPGN for patients 12 and older in January 2026.

Enable earned EU MDR CE mark approval for the enFuse syringe transfer system in March 2025. The newest amendment to the CE certification supports subcutaneous administration of Aspaveli on the enFuse platform, allowing for it to be used by caregivers and patients who are aged 12 years and up.

The wearable enFuse OBDS was engineered to streamline and improve in-clinic or patient self-administration. It delivers subcutaneous drug formulations through an injection under the skin instead of intravenously via a discreet, hands-free device using a small, hidden needle.

This extended EU certification follows recent regulatory clearance for enFuse with Empaveli in Saudi Arabia, device clearance in Brazil, marketing approval in South Korea, and Medical Device License in Canada. enFuse first gained its first combination product U.S. Food and Drug Administration (FDA) approval in 2023 for the Empaveli injector.

Comments from enFuse and others

“With this expanded CE Certification, European patients with PNH, C3G and primary IC-MPGN are now able to experience a novel way of receiving their critical medication with a delivery method that prioritizes safety, comfort and convenience,” said Michael D. Hooven, chairman and CEO of Enable Injections. “We are proud that our partnership with Sobi has resulted in the expanded availability of our wearable, patient-centric technology and look forward to bringing enFuse technology to additional international markets and ultimately to more patients.”

“The availability of ASPAVELI enFuse offers patients an administration option that greatly enhances convenience. We are empowering patients from 12 years with increased flexibility and control, strengthening their autonomy,” said Lydia Abad-Franch, chief medical officer and head of R&D at Sobi. “This regulatory decision marks a pivotal milestone in our collaboration with Enable and underscores our shared commitment to innovation, reflecting our dedication to improving the lives of people living with rare diseases.”