ZILBRYSQ zilucoplan

Drug Class

Complement component C5 inhibitor

Mechanism

Zilucoplan is a synthetic peptide that binds to complement component C5, inhibiting its cleavage into C5a and C5b, thereby preventing the assembly of the membrane attack complex at the neuromuscular junction.

Approved Indication

Treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

What This Means For Patients

Zilbrysq is a peptide C5 inhibitor approved for the treatment of generalized myasthenia gravis (gMG). It is designed for daily self-administered subcutaneous injection, targeting the complement cascade to reduce neuromuscular damage. It is available under the special-import drug policy in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2023) — label
• EMA — approved (2023) — source

Pivotal Clinical Evidence

• RAISE — Howard et al., Lancet Neurol 2023 (NCT04115293) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216834s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/zilbrysq
• https://www.ucb.com/