The U.S. Food and Drug Administration (FDA) has granted priority review to Argenx’s under-the-skin (subcutaneous) formulation of efgartigimod — the active ingredient in Vyvgart, the company’s approved treatment for generalized myasthenia gravis (gMG). If the subcutaneous formulation wins regulatory approval following that review, it would broaden the…
News
The National Institutes of Health (NIH) is supporting a pilot project that aims to develop a simple and fast diagnostic lab test for myasthenia gravis (MG). With the one-year, $100,000 NIH award, researchers at the University of California, Davis, will work to develop an assay able to identify disease-causing antibodies…
CAN106, an investigational complement-inhibiting therapy being developed by CANbridge Pharmaceuticals, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for myasthenia gravis (MG). The FDA gives orphan drug status to therapies that have the potential to treat rare disorders,…
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed to review applications seeking the approval of zilucoplan to treat generalized myasthenia gravis (gMG). UCB, the therapy’s developer, announced the FDA accepted its new drug application (NDA), requesting zilucoplan be approved to treat…
The onset of myasthenia gravis (MG) occurs at a significantly younger age in people who smoke, a study has found. Women who smoked at MG onset, or within 10 years before its onset, were significantly younger at disease onset than men. Yet, no sex differences were seen among those…
Intravenous immunoglobulin therapy was not effective at reducing the daily dose of corticosteroids for treating myasthenia gravis (MG), a multicenter Phase 2 trial shows. “These results suggest that immunomodulation alone was insufficient to facilitate dose reduction,” the researchers wrote. The trial results were reported in the study, “…
Nearly six months of treatment with telitacicept (RC18), an anti-inflammatory developed by RemeGen, safely lessened disease severity in adults with myasthenia gravis (MG) positive for acetylcholine receptor (AChR) antibodies. That’s according to new data from an ongoing Phase 2 trial in China. “The latest Phase II clinical study…
Treatment with the diabetes medication metformin suppresses the growth of immune T- and B-cell subsets that are implicated in the development of myasthenia gravis (MG), according to a study in a rat model of the neuromuscular disease. Metformin appeared to exert these positive effects by reversing the abnormal levels…
Cour Pharmaceuticals is launching a Phase 1b/2a proof-of-concept study to evaluate the safety and preliminary effectiveness of its investigational therapy CNP-106, an immune-modifying nanoparticle that’s designed to reprogram the immune system in adults with myasthenia gravis (MG). The announcement follows the U.S. Food and Drug Administration’s (FDA) approval of…
The high blood sugar levels that characterize diabetes may prompt immune cells to be activated that can drive and worsen myasthenia gravis (MG), a recent study suggests. These findings indicate that tightly controlling blood sugar levels may benefit MG patients who also have diabetes. The study, “Diabetes mellitus aggravates…
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