On October 12, RemeGen announced that Telitacicept was granted Orphan Drug designation by the US Food and Drug Administration (FDA) for the treatment of myasthenia gravis (MG). Prior to this, a phase 2 clinical study of Telitacicept in the treatment of generalized myasthenia gravis (gMG) was completed in China with positive results.
Myasthenia gravis (MG) is a rare, chronic autoimmune disease caused by antibodies against the acetylcholine receptor, muscle specific kinase or other acetylcholine receptor related proteins in the postsynaptic muscle membrane, which can lead to neuromuscular junction damage, and can affect eye movements, swallowing, speech, activity, and respiratory function to varying degrees, and nearly 85% patients will experience symptoms other than eye muscles, develop generalized myasthenia gravis (gMG), and even develop myasthenic crisis, which has been included in the First List of Rare Diseases in China.
At present, the main treatments for this disease include cholinesterase inhibitors, glucocorticoids and immunosuppressants. However, some patients are still unable to fully and effectively control the disease due to the drug efficacy, tolerance or use contraindications, and there are a large number of unmet clinical needs. Earlier this year, Telitacicept completed its phase 2 clinical trial for myasthenia gravis with positive results.