LONDON (dpa-AFX) - AstraZeneca plc (AZN.L) Monday said its investigational drug eplontersen showed sustained benefit in NEURO-TTRansform Phase 3 study in patients with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) through 66 weeks.
Eplontersen for the treatment of ATTRv-PN is under review with the FDA, with the decision date on December 22.
At 66 weeks, patients treated with eplontersen continued to demonstrate a statistically significant and clinically meaningful change from baseline versus placebo group on the co-primary endpoints of modified Neuropathy Impairment Score +7 (mNIS+7), a measure of neuropathic disease progression, AstraZeneca said.
The company also added that the results were consistent with the positive 35-week findings announced in June 2022.
ATTRv-PN is a rare, progressive disease that leads to peripheral nerve damage with motor disability and is generally fatal.
AstraZeneca, along with its partner in developing and commercializing eplontersen, Ionis Pharmaceuticals, plans to seek regulatory approval in Europe and other parts of the world.
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