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MG News
This is a collection of links to current news articles, reports and press releases related to Myasthenia Gravis.
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Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval, which follows FDA Priority Review designation, offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population of people living with gMG (adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive).
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognizing the high unmet medical need in this serious condition and the medicine’s potential to benefit patients.
The FDA has approved a new pre-filled syringe administration route for efgartigimod (Vyvgart; Argenx), a marketed medication for generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). With the decision, it offers patients greater convenience and flexibility, allowing in-home administration and reducing the number of time-consuming trips that typically come with intravenous (IV) infusions.
Researchers at UC San Diego’s School of Biological Sciences used a cutting-edge imaging technique called cryo-electron microscopy (cryo-EM) to probe details of human muscle AChRs at high resolution. As described in the journal Cell, the researchers analyzed the autoantibodies of six different myasthenia gravis patients. They discovered that these antibodies can disrupt the normal receptor functioning in a variety of ways.
https://today.ucsd.edu/story/advanced-imaging-reveals-mechanisms-that-cause-autoimmune-disease
The FDA has approved an expanded indication of eculizumab (Soliris; Alexion/AstraZeneca) to include pediatric patients 6 years and older who are living with generalized myasthenia gravis (gMG) and who are positive for antiacetylcholine receptor (AChR) antibodies, making eculizumab the first and only treatment for pediatric patients with gMG.
Johnson & Johnson announced the nipocalimab Biologics License Application (BLA) received Priority Review designation from the U.S. Food and Drug Administration (FDA) for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalized myasthenia gravis (gMG), as supported by findings from the Phase 3 Vivacity-MG3 study. The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
In the past few decades, scientists have gained substantial knowledge of the underlying pathophysiology of MG, leading to the discovery of distinct subcategories within MG. Those include MG linked to AChR or MuSK antibodies as well as age-based distinction, thymoma-associated, and immune checkpoint inhibitor–induced MG. Dr. Henry Kaminski and colleagues from MGNet have published an article outlining how this new understanding has paved the way for the development of more precise and targeted therapeutic interventions.
Surgical removal of the thymus gland has been a treatment for myasthenia gravis for more than a hundred years. Recently, concern has been raised about negative consequences for patients who undergo thymectomy for MG or resection of a thymoma. This scientific review by Dr. Henry Kaminski adopts a multidisciplinary approach to scrutinize the evidence concerning the long-term risks of cancer and autoimmunity post thymectomy. The study concludes that for patients with acetylcholine receptor antibody-positive MG and those diagnosed with thymoma, the removal of the thymus offers prominent benefits that well outweigh the potential risks.
Following implementation of low-dose rituximab as standard of care for muscle-specific kinase–positive myasthenia gravis (MuSK-MG), a hospital evaluated the treatment’s efficacy over a 2-year period. For patients who have muscle-specific kinase–positive myasthenia gravis (MuSK-MG), low-dose rituximab was proved effective.
https://www.ajmc.com/view/low-dose-rituximab-effective-against-musk-positive-mg-in-new-analysis
High levels of serum fibrinogen were found to be a sensitive and specific biomarker to identify people with myasthenia gravis (MG), according to a recent study. The plasma protein was observed in all 31 MG patients in the study.
Despite their frequency, finding help for many autoimmune diseases can prove frustrating and expensive. getting diagnosed can be a major hurdle because the range of symptoms looks a lot like those of other medical conditions, and there are often no definitive identifying tests.
