The European Commission (EC) has approved UCB’s Rystiggo (rozanolixizumab) as an add-on therapy for certain patients with generalised myasthenia gravis (gMG), a rare autoimmune disease with a global prevalence of 100 to 350 cases per one million people.
The approval specifically applies to adults who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase antibody positive, making Rystiggo the first therapy approved in Europe for both of these subtypes.
In gMG, autoantibodies target neuromuscular junction proteins. This disrupts the ability of the nerves to stimulate the muscle and results in weakness.
Patients can experience a variety of symptoms, including severe muscular weakness that can result in double vision, drooping eyelids, difficulty swallowing, chewing and talking, as well as life-threatening weakness of the muscles of respiration.
UCB’s Rystiggo, which is administered subcutaneously, is a humanised IgG4 monoclonal antibody that binds to the neonatal Fc receptor, resulting in a reduction of circulating IgG.
The EC’s decision was supported by positive results from the late-stage MycarinG study, in which treatment with Rystiggo resulted in statistically significant improvements at day 43 in gMG-specific outcomes, including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair.
The approval comes just one month after the EU regulator approved UCB’s Zilbrysq (zilucoplan) as an add-on therapy for gMG in adult patients who are anti-AChR antibody-positive.
The marketing authorisation made Zilbrysq the first once-daily subcutaneous, targeted component 5 complement inhibitor for gMG and was based on results from the late-stage RAISE study, in which Zilbrysq delivered clinically meaningful and statistically significant improvements in patient- and clinician-reported outcomes at week 12 in a broad population of adult patients with mild-to-severe anti-AChR antibody-positive gMG.
Jean-Christophe Tellier, UCB’s chief executive officer, said: “With the EC approval of [Rystiggo], alongside [its] recent approval of [Zilbrysq], I’m very excited that our gMG portfolio is now approved for use by healthcare professionals across Europe.”
“We believe there is still a significant unmet need within the gMG community which can be addressed by bringing differentiated, generally well-tolerated, and effective treatment options to patients that address key aspects of gMG pathophysiology,” Tellier added.