FDA OKs Zilbrysq autoinjector for self-administration in generalized myasthenia gravis

On October 16, 2026, UCB announced that FDA approved Zilbrysq (zilucoplan) autoinjector for self-administration in adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Zilbrysq, a complement component 5 (C5) inhibitor, blocks a protein involved in the immune-mediated damage at the neuromuscular junction in gMG. It was previously available as a self-administered prefilled syringe. The approval adds a second self-administration option for Zilbrysq and makes it the first and only macrocyclic peptide C5 inhibitor available in a once-daily autoinjector format in the US. UCB expects the device to be available commercially in the first quarter of 2027.

The decision was supported by studies showing that the autoinjector provides drug exposure equivalent to the prefilled syringe. In the phase 3b DV0013 study of 31 patients with gMG, complete dose delivery was achieved in 99.8% of administrations, and patients reported high satisfaction with self-injection. In a separate human factors study, 90% of participants successfully completed an injection on their first attempt without training.

Self-administration was generally well tolerated, with injection-site pain reported in 9.7% of patients in the DV0013 study. Labeling includes a boxed warning for serious, life-threatening, and potentially fatal meningococcal infections. Patients should complete or update meningococcal vaccination at least 2 weeks before the first dose unless delaying therapy poses greater risk. Zilbrysq is available only through the Zilbrysq Risk Evaluation and Mitigation Strategy (REMS) program, which requires prescriber enrollment and patient counseling. Common adverse reactions include injection-site reactions, upper respiratory tract infections, and diarrhea.

“For a chronic condition like gMG, having different administration options allows patients to choose the approach that best fits their individual preferences and routines,” said Donatello Crocetta, Global Head of Medical Affairs and Chief Medical Officer at UCB. “From a medical standpoint, it was essential to confirm that this added administrative option didn’t come at the expense of safety and efficacy. The data supporting the autoinjector’s complete dose delivery show that this option continues to offer effective treatment for patients.”

Source: UCB. (2026 Oct 16). UCB announces U.S. FDA approval for Zilbrysq (zilucoplan) autoinjector self-administration for adults living with generalized myasthenia gravis