By March, Immunovant plans to initiate four or five pivotal clinical trials of its lead therapeutic candidate IMVT-1402 across a range of autoimmune conditions, including myasthenia gravis (MG). Pivotal, or registrational, trials are large-scale studies whose data could support regulatory applications seeking a therapy’s approval. Immunovant announced…
Treatment with the investigational CAR T-cell therapy Descartes-08 led to deep and sustained reductions in disease severity among generalized myasthenia gravis (gMG) patients, according to top-line data from a Phase 2b clinical trial. The therapy, designed somewhat differently than others in its class, also avoided some of the potentially…
Immunovant plans to prioritize development of its newer treatment candidate, IMVT-1402, over its Phase 3 candidate, batoclimab, for people with myasthenia gravis (MG), with tentative plans to launch a registrational clinical trial program of IMVT-1402 within the next year. Registrational studies are those that can back a…
Cartesian Therapeutics’ investigational cell therapy Descartes-08 has been granted regenerative medicine advanced therapy (RMAT) designation by the U.S. Food and Drug Administration (FDA) for the treatment of myasthenia gravis (MG). RMAT status is intended for experimental regenerative medicines to treat, modify, reverse, or cure a serious or life-threatening…
No significant differences in clinical outcomes or quality of life were observed between myasthenia gravis (MG) patients treated with azathioprine or mycophenolate mofetil (MMF), results from the PROMISE-MG observational study show. While “more comparative effectiveness studies are required,” the findings “provide important information for the clinical management…
Regulators in the U.K. have approved UCB’s Rystiggo (rozanolixizumab) as an add-on treatment for adults with generalized myasthenia gravis (gMG) who are positive for antibodies that target the acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK). The decision from the Medicines and Healthcare products Regulatory Agency (MHRA) comes…
Clinical responses to the approved generalized myasthenia gravis (gMG) therapy Zilbrysq (zilucoplan) have now been sustained for more than a year among adults given long-term treatment, according to interim analyses of the Phase 3 RAISE-XT open-label extension (OLE) study. For patients who switched from a placebo in earlier clinical…
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) consistently reduced disease severity and improved quality of life across treatment cycles among adults with generalized myasthenia gravis (gMG) in an open-label extension study. With each monthlong cycle of the injectable therapy, most patients achieved a clinically meaningful reduction in the severity…
Curcumin therapy — treatment with the traditional Asian medicine, which is the main ingredient in the spice turmeric — was found to ease disease severity in a mouse model of myasthenia gravis (MG). Use of curcumin, a bright yellow chemical produced by plants, also was shown to normalize microbial…
Both high-dose intravenous methylprednisolone (IVMP) and tacrolimus effectively reduced symptom severity in patients with ocular myasthenia gravis (OMG) who failed to respond to oral steroids, a study shows. IVMP began to work quickly and more patients on it achieved a clinically meaningful treatment response over six months. “Both IVMP…
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