Marisa Wexler, MS,  senior science writer—

Zai Lab’s application seeking approval of efgartigimod in China to treat adults with generalized myasthenia gravis (gMG) has been accepted by the country’s regulatory agency, the National Medical Products Administration (NMPA). “We are pleased to have the NMPA’s acceptance of the [application] filing for efgartigimod alfa injection…

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on Phase 3 trials that are testing Sanofi’s experimental BTK inhibitor tolebrutinib. The move affects a trial in people with myasthenia gravis (MG), as well as several studies evaluating tolebrutinib for different…

Lymphoplasma exchange — a procedure that involves exchanging a patient’s plasma and also removing certain immune cells from the bloodstream — can ease symptoms of acute exacerbations of myasthenia gravis (MG), a new study reports. The study, “Lymphoplasma Exchange Improves Myasthenia Gravis Exacerbations: A Retrospective Study…

The long-acting complement inhibitor Ultomiris (ravulizumab-cwvz) has been approved by the U.S. Food and Drug Administration (FDA) to treat most adults with generalized myasthenia gravis (gMG). The approval specifically covers patients who are positive for antibodies against the acetylcholine receptor (AChR) — about 80% of gMG patients. “With the…

The European Commission is expected to propose a new governing framework for health data next month, called the European Health Data Space (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data across systems in different European nations. The move is expected to…

Treatment with Ultomiris (ravulizumab-cwvz) eased symptoms of generalized myasthenia gravis (gMG) for more than a year, according to new data from the ongoing CHAMPION-MG extension study. Findings were shared at the 2022 American Academy of Neurology (AAN) Annual Meeting in an oral presentation, titled “Long-term Efficacy and Safety of…

Many people with myasthenia gravis (MG) caused by antibodies against MuSK initially present with eye-related symptoms, which soon affect other parts of the body, according to a new study. “The present study provides a better understanding of MuSK-MG disease and its clinical course,” its researchers wrote. The study, “…

Soliris (eculizumab) is better than rituximab at controlling myasthenia gravis (MG) symptoms over a two-year period, according to a new analysis. Results were detailed in the study, “Eculizumab versus rituximab in generalised myasthenia gravis,” published in the Journal of Neurology, Neurosurgery and Psychiatry. Soliris…

Cabaletta Bio has been cleared by the U.S. Food and Drug Administration (FDA) to start first-in-human clinical testing of MuSK-CAART, a cell-based therapy being developed to improve muscle strength in people with MuSK antibody-positive myasthenia gravis and help them in their activities of daily living. “We look forward to…

The risk of myasthenia gravis (MG) worsening during pregnancy is about 34%, a new study estimates. Notably, most MG pregnancies end in vaginal delivery, and the risk of preterm birth is not increased in women with the neuromuscular condition, the study also indicates. “The current study allows the…