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…
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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,…
Barriers posed by social determinants of health can lead to a complex set of challenges — most centered on financial worry and mental health — for people with generalized myasthenia gravis (gMG), according to a small study done in the U.S. Researchers found that these challenges had an impact…
Regulators in China approved Soliris (eculizumab) for adults with hard-to-treat (refractory) generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) antibodies. With this approval, Soliris is now the first complement inhibitor available to treat gMG in the country, according to AstraZeneca, the company that…
Composition of the fungal species present in the gut — known as the fungal gut microbiota — does not differ significantly between people with myasthenia gravis (MG) and those with other neurological disorders or healthy people. That’s according to an analysis of the fungal gut microbiota of participants in…
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