FDA Approves UCB's ZILBRYSQ Autoinjector for Generalized Myasthenia Gravis
BRUSSELS — UCB (Euronext Brussels: UCB) announced on October 16 that the U.S. Food and Drug Administration has approved the ZILBRYSQ (zilucoplan) autoinjector for self-administration by adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive. Zilbrysq is the first and only macrocyclic peptide C5 inhibitor approved in the United States as a self-administered, once-daily subcutaneous autoinjector for gMG; it was previously available as a self-administered prefilled syringe following its initial U.S. approval in 2023.
The approval was supported by a phase 1 study in 14 healthy volunteers showing bioequivalence between the autoinjector and the prefilled syringe; a phase 3b study in which 99.8% of 449 autoinjector administrations achieved complete dose delivery; and a human-factors study of 100 participants — patients, caregivers and health-care professionals — in which 90% completed the injection on the first attempt without training. The most common treatment-emergent adverse event was injection-site pain, at 9.7%. Commercial availability of the autoinjector is expected in the first quarter of 2027.
Kimberly Moran, UCB's senior vice president and head of U.S. rare diseases, said in the release that the autoinjector gives people living with gMG a new self-administration option. UCB is headquartered in Brussels, Belgium, and focuses on immunology and neurology.
Published by GSM · USA (original Chinese edition)
Photo: ZILBRYSQ产品图（UCB官网） / ZILBRYSQ product image (UCB official site)
