January 6, 2023
1 minute read
The FDA has granted priority review to UCB’s biolicensing application for rosanolixizumab, a drug for the treatment of adults with generalized myasthenia gravis, the biopharmaceutical company said in a press release.
FDA Priority Review granted to European Medicines Agency (EMA) for Marketing Authorization Application for rosanolixizumab, a subcutaneous monoclonal antibody targeting adult neonatal Fc receptors, an anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody It follows a recent validation by positive.
Both the FDA and EMA submissions were based on phase 3 trial data and showed that treatment with rosanolixizumab showed clinically meaningful and significant improvement in myasthenia gravis outcomes. said the release.
“People who live together [myasthenia gravis] They suffer from unpredictable, fluctuating and debilitating symptoms that greatly affect their lives and clearly require additional targeted treatments. ” Charles van Zil UCB’s Executive Vice President of Neurology Solutions said in the release:
According to the release, rosanolixizumab significantly reduced myasthenia gravis activity on the Daily Life Scale score from baseline to day 43, achieving at least a 2-point improvement in score compared to placebo Generalized myasthenia gravis is a chronic disease in which pathogenic autoantibodies can impair synaptic transmission at the neuromuscular junction by targeting specific proteins on the postsynaptic membrane. is an unpredictable autoimmune disease. This interferes with the nerve’s ability to stimulate the muscle.
In the United States, the prevalence of generalized myasthenia gravis is estimated at 14-20 cases per 100,000 population, or approximately 36,000-60,000 cases. In Europe, the prevalence is estimated at 10 per 100,000 people.
Feedback from the FDA and EMA is expected in the second quarter of 2023, UCB said.