News

FDA Grants Argenx Priority Review for Under-the-skin Efgartigimod

The U.S. Food and Drug Administration (FDA) has granted priority review to Argenx’s under-the-skin (subcutaneous) formulation of efgartigimod — the active ingredient in Vyvgart, the company’s approved treatment for generalized myasthenia gravis (gMG). If the subcutaneous formulation wins regulatory approval following that review, it would broaden the…

CAN106 Gets FDA Orphan Drug Designation for Myasthenia Gravis

CAN106, an investigational complement-inhibiting therapy being developed by CANbridge Pharmaceuticals, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for myasthenia gravis (MG). The FDA gives orphan drug status to therapies that have the potential to treat rare disorders,…

Zilucoplan Under Review in US and EU to Treat Generalized MG

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…

Smoking Linked to Earlier Onset of MG

The onset of myasthenia gravis (MG) occurs at a significantly younger age in people who smoke, a study has found. Women who smoked at MG onset, or within 10 years before its onset, were significantly younger at disease onset than men. Yet, no sex differences were seen among those…

IVIG Not Effective at Lowering Corticosteroid Dose in MG Patients

Intravenous immunoglobulin therapy was not effective at reducing the daily dose of corticosteroids for treating myasthenia gravis (MG), a multicenter Phase 2 trial shows. “These results suggest that immunomodulation alone was insufficient to facilitate dose reduction,” the researchers wrote. The trial results were reported in the study, “…

FDA Clears Proof-of-concept Study for CNP-106 Immune Therapy

Cour Pharmaceuticals is launching a Phase 1b/2a proof-of-concept study to evaluate the safety and preliminary effectiveness of its investigational therapy CNP-106, an immune-modifying nanoparticle that’s designed to reprogram the immune system in adults with myasthenia gravis (MG). The announcement follows the U.S. Food and Drug Administration’s (FDA) approval of…