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…
Contrary to increasing evidence, high-intensity inpatient rehabilitation was not found, in a Japanese study, to speed the recovery of people with myasthenia gravis (MG) who were intubated after a myasthenic crisis. Instead, according to researchers, “high-intensity rehabilitation was associated with delayed recovery in the ADL [activities of daily living],”…
European regulators have recommended efgartigimod be approved as an add-on therapy for adults with generalized myasthenia gravis (gMG) who have anti-acetylcholine receptor (AChR) antibodies. This recommendation, from the Committee for Medicinal Products for Human Use (CHMP), will serve as the basis for a final regulatory decision from the…
Soliris (eculizumab) safely and rapidly led to clinical benefits in people with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive, according to data from a small real-world U.S. study. Moreover, most patients discontinued maintenance immunomodulatory treatment. The study, “Safety and outcomes of eculizumab for acetylcholine…
Two molecules in blood cells may be potential biomarkers for diagnosing myasthenia gravis (MG), a study suggests. Researchers found levels to be lower in mononuclear cells — a mixture of different cell types that circulate in the bloodstream and have a round nucleus — of patients with MG than…
Two doses of the COVID-19 vaccine did not worsen symptoms in 200 people with myasthenia gravis (MG), with mostly injection site-related side-effects reported, matching those seen in the general population, a study reported. These findings contrast with those of a recent study suggesting that, in very rare cases,…
People with myasthenia gravis, particularly women, have a high symptom burden that considerably affects their health-related quality of life, but the disease’s human cost is rarely given adequate study, a systematic literature review has found. Symptoms generally eased following treatment and disease remission. Still, there is…
Medison Pharma has entered into a pact with the global immunology company Argenx to bring efgartigimod to market in Israel and across several European countries for treating adult patients with generalized myasthenia gravis (gMG). The agreement sets the stage for commercialization of efgartigimod in 14 countries: Hungary, Poland, Czech…
Vyvgart (efgartigimod alfa-fcab) is being made available to eligible adults with generalized myasthenia gravis (gMG) in the U.K. under an early access to medicines scheme (EAMS), Argenx, the therapy’s developer, announced. An EAMS is designed to enable access to potentially lifesaving medications for patients with unmet medical…
Myasthenia gravis (MG) affects 20 of every 100,000 people, according to the Myasthenia Gravis Foundation of America (MGFA), which is working to help educate the public about the rare disorder as part of this year’s MG Awareness Month. MG typically affects women under the age of 40 and…
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