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.
Generalized myasthenia gravis is a chronic autoimmune disease that causes debilitating muscle weakness, often affecting the eyes, face, and swallowing. Vyvgart (efgartigimod) 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 a broader range of adult patients.
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