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 | Image: AstraZeneca
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
