Zilbrysq FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 17, 2023.
FDA Approved: Yes (First approved October 17, 2023)
Brand name: Zilbrysq
Generic name: zilucoplan
Dosage form: Injection
Company: UCB, Inc.
Zilbrysq (zilucoplan) is a peptide inhibitor of complement component 5 (C5 inhibitor) for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
- Generalized myasthenia gravis (gMG) is an autoimmune disorder characterized by muscle weakness that can be disabling or life-threatening. There are several factors that are thought to be drivers of gMG disease pathology, including the complement cascade, immune cells and pathogenic Immunoglobulin G (IgG) autoantibodies. In anti-AChR antibody-positive gMG, pathogenic AChR autoantibodies (IgG1 and IgG3) initiate the classical complement pathway, leading to the cleavage of C5 and the MAC (membrane attack complex) formation, damage to the neuromuscular junction, loss of acetylcholine receptors and subsequent impaired synaptic transmission.
- Zilbrysq contains zilucoplan, a complement C5 inhibitor that works by inhibiting complement-mediated damage to the neuromuscular junction. The exact way in which zilucoplan works is unknown, but it is thought to involve reduction of C5b-9 deposition at the neuromuscular junction. By binding to the complement protein C5, zilucoplan inhibits its cleavage to C5a and C5b, preventing the generation of the terminal complement complex, C5b-9.
- Zilbrysq is administered once daily by subcutaneous injection.
- The Zilbrysq product label carries a Boxed Warning for meningococcal infections that can be life-threatening and fatal. Zilbrysq is available only through a restricted program called the Zilbrysq REMS.
- Warnings and precautions associated with Zilbrysq include use in patients with systemic infections, and risk of pancreatitis and pancreatic cysts.
- Common adverse reactions include injection site reactions, upper respiratory tract infection, and diarrhea.
Development timeline for Zilbrysq
Further information
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