FDA Approves Zilbrysq for Myasthenia Gravis


In the past several years, a deeper understanding of the myasthenia gravis disease process has enabled the development of many new targeted medications that act quickly and with fewer side effects. Now for the first time, people with MG have a new treatment option that doesn’t require a trip to a medical provider or infusion center.

On October 17, the U.S. Food and Drug Administration (FDA) approved the targeted C5 complement inhibitor Zilbrysq (zilucoplan) for generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive, according to a press release from UCB, the manufacturer of the drug.

New Drug Offers Freedom and Flexibility

For people living with gMG, the unpredictable nature of the severity and frequency of symptoms such as muscle weakness and fatigue can be debilitating and can have a substantial impact on many aspects of their day-to-day lives, says lead investigator in the phase 3 clinical trial for Zilbrysq (the RAISE trial), James F. Howard, MD, distinguished professor of neuromuscular disease and professor of neurology, medicine, and allied health at the University of North Carolina Chapel Hill School of Medicine.

For a broad population of AChR antibody-positive gMG, Zilbrysq offers many benefits, including patient choice and patient freedom, says Dr. Howard.


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