UCB said the U.S. Food and Drug Administration (FDA) approved a daily autoinjector for ZILBRYSQ, giving adults with a specific form of myasthenia gravis another way to take the existing treatment.
ZILBRYSQ (zilucoplan) is prescribed once a day for adults with generalized myasthenia gravis (gMG) who test positive for antibodies to the acetylcholine receptor (AChR). The device delivers the medicine under the skin and joins the prefilled syringe already used for treatment.
The FDA’s public drug listing records an Oct. 15, 2026, action on supplement SUPPL-15 and classifies it as “Efficacy-New Indication.” The entry has no approval letter or updated label, so it does not describe the supplement’s scope. UCB announced the approval Oct. 16.
A Neurology abstract reported results from two studies. In a Phase 1 crossover study of 14 healthy adults, the autoinjector and syringe met bioequivalence criteria. A separate Phase 3b study followed 31 adults with gMG. Complete delivery was recorded in 448 of 449 administrations, or 99.8%, with a 95% confidence interval of 98.8% to 100%. On Day 14, the median satisfaction rating for self-injection was 8.9 on a 10-point scale. Seven participants reported treatment-emergent adverse events; all were mild and nonserious.
UCB said that in a human-factors study of 100 patients, caregivers and healthcare professionals, 90% completed an injection with the autoinjector on the first attempt without training.
The FDA first approved ZILBRYSQ in 2023 for adults with AChR-positive gMG. Its prescribing information warns of serious meningococcal infections and calls for vaccination at least two weeks before treatment. When urgent treatment cannot wait, clinicians are directed to provide antibacterial prophylaxis and vaccinate as soon as possible.
UCB projects U.S. commercial availability during the first quarter of 2027. The company has not announced a price or reimbursement terms.
