The FDA has approved a new autoinjector version of Zilbrysq (zilucoplan), a complement component 5 (C5) inhibitor, for adults with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG). Previously only available as a prefilled syringe since its 2023 approval, the once-daily subcutaneous autoinjector features automated drug delivery and a concealed needle design — aimed at making self-injection easier and more manageable for patients living with this debilitating neuromuscular condition.

The approval was backed by two clinical studies confirming the autoinjector's bioequivalence to the prefilled syringe, strong dose delivery performance, and a favorable safety profile. UCB expects the device to be commercially available in Q1 2027.

By the Numbers

• 99.8% of autoinjector administrations achieved complete dose delivery (449 devices used)
• 90% of participants in a human factors study successfully injected on their first attempt without prior training
• 9.7% of patients reported injection-site pain, the most common adverse event
• 22.6% of participants experienced treatment-emergent adverse events, all of which were mild or non-serious

Why it matters: For patients living with gMG, a more user-friendly delivery device could meaningfully improve treatment adherence and quality of life — without changing the underlying therapy. Notably, the existing boxed warning for serious meningococcal infections and REMS requirements remain in place, so vaccination and infection monitoring continue to be essential.