Vera Bril, MD, Professor of Medicine at the University of Toronto discusses the recent approval rozanolixizumab to treat myasthenia gravis.
Myasthenia gravis is a chronic autoimmune neuromuscular disease characterized by weakness of the skeletal muscles. Common symptoms include weakness of the muscles that control the eye and eyelid, facial expressions, chewing, talking, and swallowing. The condition is usually due to the presence of antibodies against the acetylcholine receptor. There is no cure for myasthenia gravis at this time, but treatment can significantly improve muscle weakness.
Recently, the US Food and Drug Administration (FDA) treated adults for both anti-AChR and anti-MuSK antibody-positive generalized myasthenia gravis. The FDA approval was largely based on data from the Phase 3 MycarinG study that was recently published in Lancet Neurology.
As noted by Dr. Bril, that study involved 200 patients who were randomized to receive once weekly injections of rozanolixizumab 7 mg/kg (n= 66), rozanolixizumab 10 mg/kg (n=67), or placebo (n=66). The primary outcome measure was a change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score and the study observed highly significant improvements in both rozanolixizumab-treated groups compared to placebo. MG-ADL assesses the impact of gMG on daily functions of eight signs or symptoms that are typically affected in gMG. These include activities such as breathing, talking, swallowing, and being able to rise from a chair. Numerous secondary outcome measures were also significantly improved by treatment with the orphan drug.
The most common adverse reactions with rozanolixizumab were headache, infections, diarrhea, pyrexia, hypersensitivity reactions, and nausea.
To learn more about myasthenia gravis, visit our learning center at checkrare.com/myasthenia-gravis/