The United States Food and Drug Administration (FDA) has just approved a novel drug for the treatment of myasthenia gravis (MG), according to a press release.
“Rozanolixizumab-noliis a new treatment option, targeting 1 of the mechanisms of disease to provide symptom improvement in patient-and physician-reported outcomes at day 43,” said Vera Bril, MD, a professor of medicine at the University of Toronto.
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This novel drug, called rozanolixizumab-noli, received FDA approval after receiving the priority review designation as a treatment option for adult patients with generalized MG. This drug is currently only approved for cases that are positive for the antiacetylcholine receptor antibody or the antimuscle-specific tyrosine kinase antibody.
Rozanolixizumab-noli is a humanized IgG4 monoclonal antibody that targets the neonatal Fc receptor, which in turn diminishes the amount of circulating IgG. Its effects on patients with MG were evaluated in the recently published clinical trial referred to as MycarinG.
It consisted of a phase 3 study that reported a statistically significant decrease in the MG-ADL and QMG scores from baseline to day 43. Moreover, the study demonstrated greater improvement in daily activities such as rising from a chair, swallowing, talking, and breathing in patients treated with rozanolixizumab-noli when compared to the placebo group.
“The approval of rozanolixizumab-noli means doctors have an additional approved treatment option for their gMG patients who have not yet found a treatment that meets their needs,” said Iris Loew-Friedrich, PhD, executive vice president and chief medical officer at UCB, who made the drug.
Regarding the safety profile, the common adverse events included headaches, nausea, diarrhea, pyrexia, infections, and hypersensitivity reactions, present in at least 10% of the patients under treatment with rozanolixizumab-noli.
UCB announces US FDA approval of RYSTIGGO[®] (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis. Published online June 27, 2023.