Top 5 Myasthenia Gravis Content of 2025

Among the top advancements in myasthenia gravis (MG) in 2025, there was a new treatment approval and research into disease burden and diagnostic indicators. Rozanolixizumab (Rystiggo; UCB) was a hot topic, with an approval in the European Union (EU) and data presented at a top conference. Additionally, the FDA approved nipocalimab (Imaavy; Johnson & Johnson) for patients 12 years and older. Research into disease burden found that MG exacerbations significantly increase overall health care costs and utilization, and investigators identified that expiratory flow detected during water swallowing may predict pharyngeal muscle weakness severity.

Here is the top content covering MG from 2025.

5. EU Approves Self-Administered Rozanolixizumab for Myasthenia Gravis

In February, the Committee for Medicinal Products for Human Use of the European Union (EU) issued positive opinions for 2 new administration forms of rozanolixizumab: via infusion through a syringe pump or via a manual push syringe, both requiring training from a health care professional prior to first self-administration. Data from the phase 3, open-label, crossover MG0020 study (NCT05681715) helped push the approvals through. Each vial of rozanolixizumab contains 140 mg/mL, and there are 4 vial sizes available: 2 mL (280 mg), 3 mL (420 mg), 4 mL (560 mg), and 6 mL (840 mg). There was a 6-week training period, two 6-week self-administration periods, and 8 weeks of observation; the primary end point was successful self-administration, and for a principal secondary end point, change in Quantitative Myasthenia Gravis (QMG) score, there were point reductions of 5.4 and 6.7 in patients randomized to receive rozanolixizumab 7 mg/kg (n = 66) and 10 mg/kg (n = 67) vs placebo.

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4. Rozanolixizumab Remains Consistently Safe, Effective for gMG

New data pertaining to the use of rozanolixizumab in the US were presented in March at the 2025 Muscular Dystrophy Association Clinical & Scientific Conference. Findings from 2 phase 3 studies, MycarinG study (MG0003/NCT03971422) and its open-label extension MG0004 (NCT04124965), demonstrated the benefits of weekly administration for 6 weeks and up to 52 weeks, respectively. Not only did rozanolixizumab improve symptoms of generalized MG (gMG), especially ocular symptoms, but it also led to significant improvements as evaluated by the Myasthenia Gravis Activities of Daily Living score, QMG score, and the MG Impairment Index. Rozanolixizumab is a high-affinity humanized immunoglobulin G4 monoclonal antibody and Fc receptor blocker approved to treat anti-acetylcholine receptor– and anti-muscle-specific kinase–positive gMG in adult patients.

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Discover the latest breakthroughs in myasthenia gravis treatment, including rozanolixizumab and nipocalimab, and insights on disease burden and dysphagia indicators. | Image Credit: © Yurii Kibalnik-stock.adobe.com

3. Exacerbations Drive Costs, Utilization in Myasthenia Gravis

A comparison of 2 groups of patients living with MG—those who experienced exacerbations of the chronic autoimmune neuromuscular disease and those who did not—showed both higher overall health care costs and rates of health care utilization for the group who experienced exacerbations. These findings were published in the Journal of the Neurological Sciences. The US Veterans Affairs National Healthcare system provided the data for this investigation, from 1999 to 2022, which included a total study population of 10,718 patients, of whom 3503 had at least 1 exacerbation. Patients in the exacerbation cohort were older at diagnosis, 71.71 years vs 68.01 years, and demonstrated a higher baseline mean Charlson Comorbidity Index score prior to being diagnosed: 0.86 vs 0.59. Mean yearly exacerbations were 1.35 (2.50), and 52% of patients who experienced exacerbations had them at least 3 times during the study. Compared with White patients, African American (HR, 1.22; 95% CI, 1.09-1.36; P < .001) and Hispanic (HR, 1.44; 95% CI, 1.25-1.65; P < .001) patients had higher risks of exacerbations.

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2. FDA Approves Nipocalimab for Generalized Myasthenia Gravis

On April 30, the FDA approved this FcRn-blocking monoclonal antibody for use in adult and pediatric patients 12 years or older who are anti-acetylcholine receptor positive or anti-muscle-specific kinase antibody positive. Data from the phase 3 Vivacity-MG3 study (NCT04951622) showed that 77 patients received nipocalimab plus standard-of-care (SOC) treatment, and their outcomes were compared with those of 76 patients who received placebo plus SOC. Reductions in immunoglobulin G levels were seen as early as the second week of treatment, and most adverse events were mild or moderate across both groups when the authors looked at infusion-related reactions, infections, and severe infections or infections. Vivacity-MG's open-label extension trial (NCT04951622) is ongoing.

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1. Researchers Identify Potential Novel Indicator of Dysphagia in MG

Dysphagia is difficulty swallowing, and it affects close to 70% of patients who have MG. In this study, a healthy control group was used to gauge the swallowing abilities of patients with MG who had dysphagia. Investigators concluded that respiratory patterns and submental surface electromyography may have predictive ability for severity of pharyngeal muscle weakness and fatigability in patients with MG. Their test lasted 10 minutes, and over that time, patients were evaluated for how they swallowed 100 mL of water. Results showed that patients with MG had a median excessive expiratory flow of 32.5 (range, 0-134) vs 2 (range, 0-29) in healthy controls (P < .001).

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