EU approval next for UCB's Zilbrysq

The European Commission (EC) has granted a marketing authorization for Zilbrysq (zilucoplan) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.

Belgian drugmaker UCB’s (Euronext: UCB) drug is the first once-daily subcutaneous (SC), targeted peptide inhibitor of complement component 5 (C5) inhibitor for gMG, and the only C5 inhibitor approved for self-administration by adult patients with AChR antibody-positive gMG.

"UCB is taking another important step forward in delivering patient value to the gMG community"This approval is supported by the pivotal Phase III RAISE study in gMG, which demonstrated that treatment resulted in statistically-significant improvements in MG-specific efficacy outcomes compared to placebo.