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AstraZeneca gets FDA green light for nerve disease treatment
(Sharecast News) - The US Food and Drug Administration has approved the Wainua nerve disease treatment jointly developed by AstraZeneca and Ionis Pharmaceuticals.
The green light marks the first-ever regulatory approval in the US for the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis.
"There is an urgent medical need for new therapies for people living with hereditary transthyretin-mediated amyloid polyneuropathy," said Ruud Dobber, executive vice president of Astra's BioPharmaceuticals Business Unit.
"The US approval of Wainua offers a new treatment option that provides consistent and sustained reduction in serum TTR concentration compared to baseline while halting disease progression and improving quality of life for people living with this debilitating condition."
The approval follows positive 35-week interim analysis from the NEURO-TTRansform Phase III trial, which showed patients treated with Wainua "demonstrated consistent and sustained benefit on the co-primary endpoints".
Additional regulatory reviews are already underway in Europe and other countries.
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