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 chronic neuromuscular disorder that causes muscle weakness, often affecting the eyes, face, and swallowing, leading to symptoms like double vision, drooping eyelids, and difficulty speaking or walking. Vyvgart (efgartigimod) is an antibody fragment that blocks a protein called FcRn, which normally recycles harmful antibodies in the body. By disrupting this process, Vyvgart reduces the levels of these antibodies, potentially easing muscle weakness and improving daily function for patients.
The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection. Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment...
Source: ClinicalTrials.gov