Amgen (AMGN) said Thursday said that a phase 3 trial of its Uplizna drug showed "durable and sustained efficacy" in patients with acetylcholine receptor autoantibody-positive generalized myasthenia gravis with just two doses a year following an initial loading dose.
The company said the study showed that 72.3% of AChR+ patients treated with Uplizna achieved an improvement of at least 3 points in the Myasthenia Gravis Activities of Daily Living score, compared with 45.2% in placebo.
Amgen previously said the trial, which also evaluated muscle-specific kinase autoantibody-positive patients, met its primary endpoint of statistically significant change from baseline in MG-ADL score at week 26 for both the MuSK+ and AChR+ patients taking Uplizna.
The company said it expects to complete filing its application for Uplizna in gMG in H1. The US Food and Drug Administration granted Orphan Drug Designation for Uplizna in gMG.
The drug is currently approved for the treatment of adults with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder and is under priority review by the FDA for Immunoglobulin G4-related disease with a target action date of April 3.
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