The US Food and Drug Administration (FDA) has granted clearance to UCB’s ZILBRYSQ (zilucoplan) for the treatment of generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive.
Zilucoplan is a targeted peptide inhibitor of complement component 5 (C5), designed for self-administration through the subcutaneous (SC) route.
It inhibits complement-mediated damage to the neuromuscular junction and can be used along with intravenous immunoglobulin and plasma exchange.
The approval of ZILBRYSQ is based on data from the placebo-controlled, double-blind, randomised, multi-centre Phase III RAISE study.
The study evaluated the efficacy and safety of zilucoplan in adult patients with anti-AChR antibody-positive gMG who received SC injections of 0.3 mg/kg zilucoplan or placebo in a 1:1 ratio daily for 12 weeks.
At week 12, treatment with zilucoplan delivered significant benefits in patient-and-clinician-reported outcomes in a broad population of these patients.
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Injection site reactions, upper respiratory tract infection and diarrhoea were some of the most common adverse reactions, observed in 10% of patients who received zilucoplan injections.
Zilucoplan also demonstrated an improvement from baseline against placebo for myasthenia gravis activities of daily living and quantitative myasthenia gravis total scores.
UCB executive vice-president and chief medical officer Iris Loew-Friedrich stated: “Until now, people living with gMG have only had access to C5 therapy intravenously, which can be inconvenient and time-consuming.
“Now, with the option of zilucoplan, a self-administered once-daily, subcutaneous targeted complement C5 inhibitor, we hope a broad population of mild-to-severe adult patients with AChR-antibody-positive gMG will be able to have greater independence.
“Alongside our FcRn blocker rozanolixizumab-noli, which was approved and launched in the US earlier this summer, our unique portfolio will support patients and healthcare professionals to tailor the choice of treatment according to their individual needs.”
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