Shots:
- The US FDA has approved UCB’s Zilbrysq (zilucoplan) autoinjector for once-daily self-administration in adults with generalized myasthenia gravis (gMG) who are anti-AChR antibody positive, adding to the existing prefilled syringe option
- Supportive data incl. P-I (DV0012) bioequivalence vs PFS in healthy volunteers (n=14) and P-IIIb (DV0013) in adults with gMG (n=31), where complete dose delivery was achieved for 99.8% (n=449) of autoinjector administrations; self-administration was generally well tolerated, with injection-site pain the most common TEAE (n=3; 9.7%)
- Zilbrysq is a once-daily SC macrocyclic peptide C5 inhibitor; UCB expects the autoinjector to be commercially available in Q1’27
Ref: UCB | Image: UCB | Press Release
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