The U.S. Food and Drug Administration has granted orphan drug status to NMD670, an experimental oral therapy that NMD Pharma is developing as a potential treatment for myasthenia gravis (MG). The designation is given to therapies intended for treating rare diseases, defined as those affecting fewer than…
Argenx has submitted an application to the U.S. Food and Drug Administration (FDA) requesting the approval of subcutaneous efgartigimod — an under-the-skin formulation of the active agent in Vyvgart — for the treatment of generalized myasthenia gravis (gMG). FDA approval would provide gMG patients with an additional delivery…
The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Ultomiris (ravulizumab) for treating generalized myasthenia gravis (gMG). The approval covers adults positive for antibodies against the acetylcholine receptor (AChR) — the most common type of MG-driving autoantibody — and who either don’t respond adequately to…
The European Commission has approved Vyvgart (efgartigimod) as an add-on to standard treatment for adults with generalized myasthenia gravis (gMG) who are positive for antibodies against acetylcholine receptor (AChR), the most common type of MG-driving antibody. “We share the excitement with the European gMG community in bringing a…
A combination of glucocorticoids and intravenous immunoglobulin (IVIG) is more effective at normalizing immune responses and easing disease symptoms in children with ocular myasthenia gravis (OMG) than glucocorticoids alone, a study showed. The combination also could allow for a shorter duration and lower dose of glucocorticoids, also known…
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…
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…
Lymphoplasma exchange — a procedure that involves exchanging a patient’s plasma and also removing certain immune cells from the bloodstream — can ease symptoms of acute exacerbations of myasthenia gravis (MG), a new study reports. The study, “Lymphoplasma Exchange Improves Myasthenia Gravis Exacerbations: A Retrospective Study…
The long-acting complement inhibitor Ultomiris (ravulizumab-cwvz) has been approved by the U.S. Food and Drug Administration (FDA) to treat most adults with generalized myasthenia gravis (gMG). The approval specifically covers patients who are positive for antibodies against the acetylcholine receptor (AChR) — about 80% of gMG patients. “With the…
The European Commission is expected to propose a new governing framework for health data next month, called the European Health Data Space (EHDS), with the aim of connecting national health systems to facilitate secure and efficient transfer of data across systems in different European nations. The move is expected to…
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