News

Ultomiris (ravulizumab) has been recommended for approval in the European Union (EU) as an add-on therapy for most adults with generalized myasthenia gravis (gMG). The recommendation by the Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, specifically covers gMG patients who are positive…

Plasma exchange combined with intravenous, or into-the-vein, immunoglobulin (IVIG) appears to be safe, and better than plasma therapy alone at easing the symptoms of myasthenia gravis (MG) and boosting the immunity of patients, a study suggests. These findings offer what researchers called a “reference for clinical decision-making” — particularly…

The Moderna COVID-19 vaccine was safe and did not particularly worsen clinical symptoms in people with myasthenia gravis (MG), a Spanish study reported. Patients developed a robust immune response after receiving the two recommended doses, despite being on immunosuppressive therapies. Additionally, no participant developed COVID-19 throughout the study. The…

Nonprofits, scientists, governmental organizations, and the rare disease drug development industry have long cited 7,000 as the average number of rare diseases in the world. But a new analysis shows there are as many as 10,867 rare diseases globally. And that…

Zai Lab’s application seeking approval of efgartigimod in China to treat adults with generalized myasthenia gravis (gMG) has been accepted by the country’s regulatory agency, the National Medical Products Administration (NMPA). “We are pleased to have the NMPA’s acceptance of the [application] filing for efgartigimod alfa injection…

A man developed signs of myasthenia gravis (MG) with eye symptoms about a month after receiving the first shot of Oxford-AstraZeneca’s COVID-19 vaccine, a case study reports. “This case report implies that COVID-19 vaccination may cause myasthenia gravis with ocular symptoms,” the researchers wrote. “But we should also consider…

Generalized myasthenia gravis (gMG) may be associated with a deficiency in a type of immune cell called myeloid-derived suppressor cells (MDSCs), a study suggests, and that restoring their function and increasing their numbers may help reduce symptoms. Treatment with immunosuppressants resulted in an expansion of MDSCs, which was linked…

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…