Alnylam says Apollo Phase 3 trial of patisiran published in NEJM

Alnylam Pharmaceuticals announced that the pivotal study results from the Apollo Phase 3 trial of patisiran were published online today in The New England Journal of Medicine. The study showed that patisiran improved measures of polyneuropathy, quality of life, activities of daily living, ambulation, nutritional status, and autonomic symptoms relative to placebo in patients with hereditary transthyretin-mediated amyloidosis, the company said. Patisiran treatment also led to favorable effects on exploratory endpoints related to cardiac structure and function in patients with cardiac involvement, it added. Further, the frequency and severity of adverse events were similar in patients receiving patisiran and placebo, with the exception of peripheral edema and infusion-related events which were higher in patisiran-treated patients and generally mild to moderate in severity. “We are extremely pleased with the publication of this landmark manuscript, the first-ever pivotal RNAi clinical trial to be published in a top-tier, peer-reviewed medical journal,” said Akshay Vaishnaw, President of Research and Development at Alnylam

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