Ionis Reports the US FDA’s Acceptance of NDA for Eplontersen to Treat Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Shots:
- The US FDA has accepted the NDA for review of eplontersen to treat patients with ATTRv-PN. The US FDA’s decision is expected on Dec. 22, 2023
- The NDA was based on the P-III study (NEURO-TTRansform) evaluating eplontersen in 168 patients which showed a significant & clinical change from baseline for its co-1EPs and 2EPs over PBO in the 35wk. interim analysis, the significant mean reduction in the co-1EPs of serum transthyretin (TTR) concentration, the treatment effect on the co-1EP of mNIS+7
- The study met its 2EPs of change from baseline in Norfolk QoL-DN, improved patient-reported QoL, and a favorable safety and tolerability profile. Eplontersen is also being studied in the P-III study (CARDIO-TTRansform) for transthyretin amyloid cardiomyopathy
Ref: PRNewswire | Image: Ionis
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