News

The home infusion company KabaFusion has announced that UCB has tapped it as a limited U.S. distribution partner for Rystiggo (rozanolixizumab-noli), the first therapy approved for adults with the two most common subtypes of generalized myasthenia gravis (gMG). Following its June approval by the U.S. Food…

The approval of Soliris (eculizumab) in the European Union now extends to children and adolescents, ages 6 to 17, with generalized myasthenia gravis (gMG). The European Commission decision covers Soliris’ use in children who have refractory disease, meaning they have failed to respond to standard treatments, and are…

Most people with childhood-onset myasthenia gravis (CMG) experience milder clinical symptoms and a better prognosis than those with adult forms of the disease, according to a recent study in China. For most CMG patients, their disease could be safely controlled with prednisone and other immunosuppressive agents. Researchers also found…

The targeted generalized myasthenia gravis (gMG) treatment Rystiggo (rozanolixizumab-noli) is now commercially available by prescription in the U.S. for eligible adults with gMG, including individuals with antibodies against either the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK), according to its developer. In late June, the therapy from…

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…