UCB Canada has obtained authorisation from Health Canada for Zilbrysq (zilucoplan injection) to treat generalised myasthenia Gravis (gMG).

The company, which is a subsidiary of Belgium-based biopharmaceutical company UCB, has received approval for the use of Zilbrysq in adult gMG patients who are anti-acetylcholine receptor (AChR) antibody positive.

Zilbrysq is a C5 inhibitor that prevents complement-mediated damage to the neuromuscular junction via its targeted mechanism of action.

It was approved in the US for the same indication in October last year.

Health Canada approved the drug based on UCB’s multi-centre, Phase 3, randomised, double-blind, placebo-controlled RAISE study.

RAISE was intended to assess the safety, efficacy, and tolerability of zilucoplan in adult patients with AChR antibody-positive gMG.

In the late-stage trial, the participants were randomised in a 1:1 ratio to receive once daily subcutaneous injection of 0.3mg/kg zilucoplan or placebo for 12 weeks.

In the RAISE study, the primary endpoint was the change in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) score from baseline to Week 12.

Secondary endpoints included changes from baseline to Week 12 in the Quantitative Myasthenia Gravis (QMG) score, the Myasthenia Gravis Composite (MGC) score, and the Myasthenia Gravis Quality of Life 15 revised (MG-QoL15r) score.

According to the findings, zilucoplan provided quick, consistent, statistically significant, and clinically meaningful benefits across various patient- and clinician-reported outcomes.

These included improvements in MG-ADL score, QMG score, MGC score, and MG-QoL15r at week 12.

Furthermore, the patients who completed the RAISE trial had the option to participate in the open-label extension study, RAISE-XT.

UCB Canada country lead Rodrigo Reis said: “Health Canada’s approval of Zilbrysq marks a significant milestone for UCB Canada. As our first step in supporting the gMG community in Canada, this achievement represents a breakthrough in a new therapeutic area for our company.

“Looking ahead, we are hopeful that we will have two approved therapeutic solutions for gMG patients by the end of 2024.

“Our focus remains on pioneering scientific solutions that elevate the standard of care, enhancing the lives of those affected by gMG and other rare diseases.”

UCB Canada expects Zilbrysq to be available for supply in Q4 2024.

Last year, UCB secured the US Food and Drug Administration (FDA) approval for Rystiggo (rozanolixizumab-noli) to treat gMG.