for generalized myasthenia gravis — all adult patients (label expansion)
FDA approved label expansion for Vyvgart and Vyvgart Hytrulo to cover all adult patients with generalized myasthenia gravis (gMG), broadening eligibility beyond the previously approved anti-AChR antibody-positive subset. Approval lands ~2 months ahead of the assigned PDUFA, materially expanding the addressable population.
Myasthenia gravis is a neuromuscular disease that causes progressive weakness in the skeletal muscles, often affecting the eyes, face, and swallowing. Vyvgart is an antibody fragment that blocks a specific receptor (FcRn), which normally recycles disease-causing antibodies. By accelerating the removal of these harmful antibodies, the drug may help restore muscle strength in affected adults.
The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years)
Source: ClinicalTrials.gov