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On June 27, Rystiggo became the first generalized myasthenia gravis (gMG) treatment to be approved by the U.S. Food and Drug Administration (FDA) for adults with antibodies against either the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) proteins. While other treatments have been cleared for patients with anti-AChR…

Patterns of facial weakness can be quantified with facial recognition software and computer models and used to diagnose and monitor myasthenia gravis (MG), a study finds. “This study delivers a ‘proof of concept’ for a [deep learning] model that can distinguish MG from [healthy controls] and classifies disease…

An under-the-skin formulation of efgartigimod is now being considered for approval in China for treating adults with generalized myasthenia gravis (gMG), according to Zai Lab, which will market the therapy if approved. Chinese authorities have agreed to review a biologics license application (BLA) seeking the approval of this…

The National Medical Products Administration (NMPA) of China has agreed to consider approving batoclimab (HBM9161) for treating generalized myasthenia gravis (gMG). Submitted as a biologics license application (BLA), the request is supported by positive top-line data from a Phase 3 clinical trial (NCT05039190) from China. The trial…

Vyvgart (efgartigimod alfa) has been approved in China as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG). The approval, announced by the therapy’s developer Argenx and its partner Zai Lab, was made by the Chinese regulatory agency the National Medical Products Administration (NMPA). The approval is…

Descartes-08, an investigational RNA-based CAR T-cell therapy (rCAR-T), safely eased disease symptoms for up to nine months after treatment among 14 adults with generalized myasthenia gravis (gMG) taking part in a Phase 1b/2a clinical trial. The open-label MG-001 trial (NCT04146051), now a recruiting Phase 2b study, is the…

The U.S. Food and Drug Administration (FDA) has approved rozanolixizumab, under the brand name Rystiggo, to treat adults with generalized myasthenia gravis (gMG) who have antibodies against the acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK) proteins. Rystiggo is now the only FDA-approved therapy for patients with anti-AChR…

A branch of the European Medicines Agency (EMA) recommended that the approval of Soliris (eculizumab) be expanded to include children and adolescents, ages 6 to 17, with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR) — the most common type of MG-driving…

People with myasthenia gravis (MG) benefit from thymectomy — surgery to remove the thymus gland — regardless of whether they have early- or late-onset disease or a tumor in the thymus, a study from Germany has found. The study, “The impact of thymectomy in subgroups of Myasthenia…

Note: This story was updated June 28, 2023, to correct the time frame of the ADAPT-SC+ clinical trial, in which patients will be treated for up to 3.5 years. The U.S. Food and Drug Administration (FDA) has approved Argenx’s under-the-skin formulation of efgartigimod, now called Vyvgart Hytrulo,…