FDA approves Zilbrysq to treat generalized myasthenia gravis

The FDA has approved UCB’s Zilbrysq for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.

According to a press release from UCB, Zilbrysq (zilucoplan) is the first once-daily subcutaneous targeted peptide inhibitor of complement component 5 (C5 inhibitor), which can be self-administered by those with the condition.

Approval by the FDA was supported by data from the RAISE clinical trial, a multicenter, phase 3, randomized, double-blind, placebo-controlled study that examined safety, efficacy and tolerability of the novel therapeutic, UCB said in the release.

In that trial, the company reported, Zilbrysq delivered rapid, consistent and statistically significant benefits in different patient- and clinician-reported outcomes at week 12, with the most common adverse events being injection site reactions, upper respiratory tract infection and diarrhea.

“In addition to muscle weakness, people living with [generalized myasthenia gravis] experience fatigue, affecting their overall quality of life,” James F. Howard, MD, lead investigator in the RAISE trial, said in the release. “Zilucoplan ... provides a new treatment option for a broad population of [anti-acetylcholine receptor] antibody-positive gMG patients.”

Zilbrysq joins UCB’s neonatal Fc receptor blocker Rystiggo (rozanolixizumab-noli), approved earlier this year by the FDA to treat the condition, as therapeutic options for health care professionals to either address or complement activation of pathogenic auto-antibodies for appropriate patients.