News

An under-the-skin formulation of efgartigimod is now being considered for approval in China for treating adults with generalized myasthenia gravis (gMG), according to Zai Lab, which will market the therapy if approved. Chinese authorities have agreed to review a biologics license application (BLA) seeking the approval of this…

The National Medical Products Administration (NMPA) of China has agreed to consider approving batoclimab (HBM9161) for treating generalized myasthenia gravis (gMG). Submitted as a biologics license application (BLA), the request is supported by positive top-line data from a Phase 3 clinical trial (NCT05039190) from China. The trial…

Vyvgart (efgartigimod alfa) has been approved in China as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG). The approval, announced by the therapy’s developer Argenx and its partner Zai Lab, was made by the Chinese regulatory agency the National Medical Products Administration (NMPA). The approval is…

Deborah skydives over Longmont, Colorado. (Photos courtesy of Deborah White) This is Deborah White’s story: After several months of sporadic double vision, I started to experience drooping eyelids while on a business trip. A concerned co-worker took me to the emergency room where the physician recommended that I…

Descartes-08, an investigational RNA-based CAR T-cell therapy (rCAR-T), safely eased disease symptoms for up to nine months after treatment among 14 adults with generalized myasthenia gravis (gMG) taking part in a Phase 1b/2a clinical trial. The open-label MG-001 trial (NCT04146051), now a recruiting Phase 2b study, is the…

(Photos courtesy of Jennifer Thompson) This is Jennifer Thompson’s story: When I signed up to share a specific way in which myasthenia gravis (MG) has affected me, I had to really pause and pray. Wow! Living with MG takes a toll in so many different ways, it…

The U.S. Food and Drug Administration (FDA) has approved rozanolixizumab, under the brand name Rystiggo, to treat adults with generalized myasthenia gravis (gMG) who have antibodies against the acetylcholine receptor (AChR) or muscle-specific tyrosine kinase (MuSK) proteins. Rystiggo is now the only FDA-approved therapy for patients with anti-AChR…

(Photo courtesy of Kathi Timothy) This is Kathi Timothy’s story: As a child, I remember pleading with my mother to please believe me. Believe me that I will clean my room after I go to a friend’s house. Believe me that I really did study. Believe me. Decades later,…

A branch of the European Medicines Agency (EMA) recommended that the approval of Soliris (eculizumab) be expanded to include children and adolescents, ages 6 to 17, with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR) — the most common type of MG-driving…

(Photo courtesy of Andrea Barlass) This is Andrea Barlass’ story: Living with myasthenia gravis (MG) has been interesting, for the lack of a better word. Despite the amount of research I did after I was diagnosed, no amount of information could have prepared me for how…