News

Telitacicept Wins Orphan Drug Status to Treat Myasthenia Gravis

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 Shows Signs of Efficacy in Small Phase 1/2a Trial

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…

Immunosuppressive Therapy Tied to More COVID-19 Hospitalization Risk

People with myasthenia gravis (MG) who are receiving immunosuppressive therapy are more likely to be hospitalized for a COVID-19 infection, yet the majority of patients are discharged without any complications, a single center study reports. “Immunosuppressive therapy was continued during COVID-19 infection,” and “most of hospitalized patients were discharged…

Findings in UCB’s Myasthenia Gravis Pivotal Trials Detailed

Two investigational UCB treatments for generalized myasthenia gravis (gMG) — zilucoplan and rozanolixizumab — continue to show benefits in gMG patients, according to recently reported findings from Phase 3 trials. Both delivered as subcutaneous (under-the-skin) injections, zilucoplan works by blocking an immune system protein called C5 that…

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…