Tag: Myasthenia Gravis

Regulatory Approval Autoimmune Diseases News

Amgen Wins EU Approval for UPLIZNA in Rare Muscle-Weakening Disease, Opening New Front in Autoimmune Battle

amgen

The European Commission has granted approval for Amgen’s UPLIZNA® (inebilizumab) as an add-on treatment for adults with generalized myasthenia gravis making it the first and only CD19-targeted therapy authorized in Europe for this rare, debilitating autoimmune muscle disease. The approval is backed by pivotal Phase 3 data from the landmark MINT trial.

Clinical Trials Healthcare & Pharmaceuticals News

AstraZeneca’s Gefurulimab Shows Major Promise in Late-Stage Myasthenia Gravis Trial

AstraZeneca

AstraZeneca announced that its novel nanobody, gefurulimab, has successfully met its primary and all secondary endpoints in the PREVAIL Phase III trial for adults with generalized myasthenia gravis (gMG). The results showed that the once-weekly, self-administered treatment delivered statistically significant and clinically meaningful improvements in daily living activities for patients with this rare autoimmune disease.