New Uplizna data drop in myasthenia gravis, while clock ticks on IgG4 decision

New Myasthenia Gravis Data

Amgen reported positive 52-week data from the Phase 3 MINT trial evaluating Uplizna in generalized myasthenia gravis (gMG)1 15.
The trial demonstrated durable and sustained efficacy of Uplizna in acetylcholine receptor autoantibody-positive (AChR+) gMG patients with two doses per year, after an initial loading dose1 15.

- Key efficacy results at 52 weeks:

Uplizna showed a 2.8 point greater improvement vs placebo on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score1 11.
72.3% of Uplizna patients had a ≥3 point MG-ADL improvement vs 45.2% on placebo1 14.
69.2% of Uplizna patients had a ≥3 point improvement on the Quantitative Myasthenia Gravis (QMG) score vs 41.8% on placebo1.
- The safety profile was consistent with previous studies, with no new safety signals identified1 3.

Pending IgG4-Related Disease Decision

Uplizna is currently under FDA priority review for the treatment of IgG4-related disease (IgG4-RD)1.
The PDUFA date for the FDA's decision on Uplizna for IgG4-RD is coming up soon, though the exact date was not specified in the search results1.
This potential approval would be based on positive results from the Phase 3 MITIGATE trial in IgG4-RD, which showed an 87% reduction in disease flare risk with Uplizna vs placebo2 7.

In summary, Amgen has released promising long-term data for Uplizna in myasthenia gravis, while awaiting an FDA decision on expanding its use to IgG4-related disease in the near future. The new gMG data further supports Uplizna's efficacy in autoimmune neurological conditions.