US biotech major Amgen (Nasdaq: AMGN) has announced new data from the Phase III MINT trial of Uplizna (inebilizumab-cdon) in adults living with generalized myasthenia gravis (gMG).
The results demonstrated durable and sustained efficacy of Uplizna in patients with acetylcholine receptor autoantibody-positive (AChR+) gMG with two doses a year, following an initial loading dose.
As previously announced, the trial met its primary endpoint, with a statistically-significant change from baseline in myasthenia gravis activities of daily living (MG-ADL) score for Uplizna compared with placebo at week 26 for the combined study population. No new safety signals were identified.
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