AstraZeneca and Ionis’ Wainzua (Eplontersen) Receives the CHMP’s Positive Opinion to Treat Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy
Shots:
- The opinion of Wainzua for ATTRv-PN (stage 1/2 polyneuropathy) was supported by its P-III (NEURO-TTRansform) study vs external PBO for over wk.66, with a follow-up until wk.85 & an end-of-trial evaluation. Eligible patients could then enter an ongoing OLE study
- Study depicted sustained benefits in co-1EPs of serum transthyretin (TTR) levels & neuropathy impairment (mNIS+7) as well as 2EP of QoL (Norfolk QoL-DN) over 66wks., with a favorable & tolerable safety
- Eplontersen is under P-III (CARDIO-TTRansform) trial for transthyretin-mediated amyloid cardiomyopathy with 1,400 subjects. Both the companies are commercializing Wainzua for ATTRv-PN in the US & pursuing approval in the EU & ROW (AstraZeneca holds exclusive rights)
Ref: AstraZeneca & Ionis | Image: AstraZeneca & Ionis| Press Release
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