Shots:
- The US FDA has approved Amgen‘s Uplizna for the treatment of AChR & MuSK antibody positive adults with generalized myasthenia gravis (gMG)
- Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading dose followed by 2 doses/year; pts on steroids began tapering at Wk. 4, reducing to prednisone (5mg/day) by Wk. 24 & by Wk. 26, 87.4% on Uplizna vs 84.6% on PBO achieved ≤5 mg/day
- Trial showed a 1.9-point MG-ADL improvement with Uplizna vs PBO at Wk. 26 (-4.2 vs -2.2), with benefits sustained in AChR+ pts through Wk. 52, showing a 2.8-point difference (-4.7 vs -1.9) in exploratory analysis
Ref: Amgen | Image: Amgen |Press Release
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