Amgen shares positive late-stage results for Uplizna in generalised myasthenia gravis
Amgen has shared positive top-line results from a late-stage trial of its B cell-depleting therapy Uplizna (inebilizumab-cdon) in adults with generalised myasthenia gravis (gMG).
The phase 3 MINT trial has been evaluating the efficacy and safety of the drug in both acetylcholine receptor autoantibody-positive and muscle-specific kinase autoantibody-positive gMG patients.
Up to 100,000 people in the US are affected by myasthenia gravis, a rare autoimmune disorder that impairs neuromuscular communication and causes muscle weakness, with gMG accounting for approximately 85% of all cases.
The disease is seen more frequently in women aged 20 to 30 years and men aged 50 years and older, and causes symptoms such as trouble breathing, difficulty swallowing and impaired speech and vision.
Results from MINT, presented at this year’s American Association of Neuromuscular and Electrodiagnostic Medicine Annual Meeting, demonstrated a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living score for Uplizna compared with placebo at week 26 in the combined study population, meeting the study’s primary endpoint.
The drug also demonstrated statistically significant and clinically meaningful changes from baseline compared to placebo for key secondary endpoints, including change in Quantitative Myasthenia Gravis score for the combined population at week 26.
Amgen added that patients who entered the study taking corticosteroids were tapered down starting at week four to prednisone 5mg per day by week 24, and no new safety signals were identified.
Amgen said it is planning to file for US approval of Uplizna in this indication, followed by other key markets.
The drug already holds approvals to treat certain adults with neuromyelitis optica spectrum disorder, a rare autoimmune disease that attacks the optic nerve, spinal cord, brain and brainstem.
