FDA Approves Zilbrysq Autoinjector for Self-Administration in Generalized Myasthenia Gravis

The Food and Drug Administration (FDA) has approved a once-daily, self-administered autoinjector for Zilbrysq (zilucoplan; UCB, Brussels, Belgium) for adults with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG). The approval provides an additional administration option for Zilbrysq, a complement component 5 (C5) inhibitor previously available as a self-administered prefilled syringe.

The approval was supported by findings from 2 clinical studies evaluating the autoinjector's pharmacokinetic equivalence, dose delivery, usability, and tolerability. The phase 1 DV0012 study enrolled 14 healthy adults in an open-label crossover design comparing autoinjector and prefilled syringe administration. The phase 3b DV0013 study evaluated once-daily autoinjector self-administration in 31 adults with gMG. A separate human factors validation study assessed device usability among 100 participants, including patients, caregivers, and health care professionals.

What the Data Showed

• Bioequivalence: The phase 1 study established bioequivalence between Zilbrysq administered by autoinjector and prefilled syringe.
• Dose delivery: Complete dose delivery was achieved in 99.8% of autoinjector administrations (449 devices used and returned) in the phase 3b study.
• Usability: In the human factors study, 90% of participants successfully completed an injection on their first attempt without training.
• Safety and tolerability: Self-administration was generally well tolerated. Injection-site pain was the most common treatment-emergent adverse event, reported in 3 patients (9.7%) in DV0013.

Clinical Implications for Practicing Neurologists

The approval expands self-administration options for eligible adults with AChR antibody-positive gMG without introducing a new therapeutic agent. Neurologists can consider patient preferences, injection technique, and device usability when discussing the autoinjector and prefilled syringe options.

Zilbrysq retains its boxed warning for serious meningococcal infections and remains subject to Risk Evaluation and Mitigation Strategy (REMS) requirements. Meningococcal vaccination and infection monitoring remain essential. UCB anticipates commercial availability of the autoinjector in the first quarter of 2027.

Source

UCB. UCB announces U.S. FDA approval for ZILBRYSQ (zilucoplan) autoinjector self-administration for adults living with generalized myasthenia gravis. Press release. Published October 16, 2026. https://www.ucb.com/newsroom/press-releases/article/ucb-announces-us-fda-approval-for-zilbrysqr-zilucoplan-autoinjector-self-administration-for-adults-living-with-generalized-myasthenia-gravis