Back in December, UCB released the results of its phase 3 trial of rozanolixizumab in adult patients with generalized myasthenia gravis (gMG). Fortunately, these data were positive, pointing to this monoclonal antibody as a viable treatment for this rare disease.
Rozanolixizumab for gMG
Rozanolixizumab was compared to a placebo in adult gMG patients, with a primary endpoint of clinically meaningful change from baseline on the Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score after 43 days. This endpoint was met, as were all of the secondary endpoints. Additionally, no new safety signals were found, and the drug was well tolerated.
While there is no safety and efficacy profile for rozanolixizumab yet, final data is expected at future medical meetings this year. If all goes as planned, UCB can begin regulatory filings in the United States, Japan, and the European Union in the third quarter of 2022.
About Myasthenia Gravis
Myasthenia gravis (MG) is the most common autoimmune neuromuscular disorder. Those affected experience weakness in the voluntarily controlled muscles. Physical activity worsens the symptoms, whereas periods of rest can improve them. Throughout the world, about 20 of every 100,000 people have MG. It is an autoimmune condition, meaning the body attacks itself, specifically the proteins that are necessary for communication between the brain and muscles. This causes symptoms like drooping eyelids, issues with chewing and swallowing, fatigue and weakness in the skeletal muscles, slurred speech, double vision, and a changed gait. For a small percentage of those with MG, weakness in the chest could lead to life-threatening respiratory issues.
Doctors diagnose this condition through a physical exam, evaluation of patient history, blood tests, and EMGs. Like many rare disorders, a diagnosis is not always easy to obtain. The similarity of symptoms to other conditions often results in a misdiagnosis. After doctors have confirmed that one has MG, treatment consists of steroids, plasmapheresis, or surgery to remove the thymus gland. While there is no cure, some medications can greatly improve symptoms or even induce remission.
Looking Forward
These results are very exciting for gMG patients, as it points to a possible new treatment option. Even more exciting, UCB is conducting clinical trials for zilucoplan, another investigational myasthenia gravis treatment. The results from this study are expected within the next few weeks, and they could provide even more positivity for gMG patients and medical professionals alike.
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