Marisa Wexler, MS,  senior science writer—

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have agreed to review applications seeking the approval of zilucoplan to treat generalized myasthenia gravis (gMG). UCB, the therapy’s developer, announced the FDA accepted its new drug application (NDA), requesting zilucoplan be approved to treat…

The high blood sugar levels that characterize diabetes may prompt immune cells to be activated that can drive and worsen myasthenia gravis (MG), a recent study suggests. These findings indicate that tightly controlling blood sugar levels may benefit MG patients who also have diabetes. The study, “Diabetes mellitus aggravates…

Telitacicept (RC18), an anti-inflammatory therapy developed by RemeGen, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for myasthenia gravis (MG). Orphan drug designation, or ODD, is given to therapies that have the potential to treat rare diseases, defined…

NMD670 safely improved muscle function and strength in a small clinical trial of people with myasthenia gravis (MG), the therapy’s developer, NMD Pharma, announced. “These trial results represent an important milestone for NMD Pharma as they provide the first clinical proof of mechanism for our novel ClC-1 inhibitor…

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…