News

Ultomiris Approved in Europe for Adults With AChR-positive gMG

The European Commission has approved Ultomiris (ravulizumab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG). Eligible patients will be positive for antibodies targeting the acetylcholine receptor (AChR) — the most common type of MG-causing antibody. Ultomiris is now the first long-acting C5 complement…

FDA Approval Sought for Under-the-skin Efgartigimod for gMG

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…

Onset of MG Following Sinopharm’s COVID-19 Vaccine Reported

Researchers in Iran reported the first case of myasthenia gravis (MG) following a Sinopharm vaccination against SARS-CoV-2, the virus that causes COVID-19. The report follows evidence of a possible link between COVID-19 vaccination and MG. While the mechanisms remain unclear, “if muscle weakness, ocular and bulbar [neck and facial]…

Subcutaneous IG Found Effective for MG Adults in Small Study

Subcutaneous immunoglobulin therapy (SCIg) — given by under-the-skin injection — was well-tolerated and effective in the management of adults with myasthenia gravis (MG), a small study has found. Although the therapy is approved for other diseases related to immune system deficiency, and is currently under investigation as an…

Spherix Analyzes Reviews of gMG Therapies, Vyvgart, Ultomiris

Neurologists find both Vyvgart (efgartigimod) and Ultomiris (ravulizumab-cwvz) effective for treating generalized myasthenia gravis (gMG), but believe Ultomiris has a more convenient dosing schedule while Vyvgart may have a better safety profile. That’s according to a recent analysis by the market intelligence firm Spherix Global Insights.

Ultomiris Approved in Japan as Treatment for AChR-Positive gMG

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…