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BRIEF-Alnylam's genetic disease drug meets main goal in phase 3 study
2017年9月20日 / 下午12点36分 / 1 个月前

BRIEF-Alnylam's genetic disease drug meets main goal in phase 3 study

Sept 20 (Reuters) - Alnylam Pharmaceuticals Inc

* Sanofi and Alnylam report positive topline results from APOLLO phase 3 study of patisiran in Hereditary ATTR (HATTR) amyloidosis patients with polyneuropathy

* Alnylam Pharmaceuticals Inc - intends to file new drug application (NDA) in late 2017 and marketing authorisation application (MAA) in early 2018‍​

* Alnylam Pharmaceuticals - ‍​investigational RNAI therapeutic patisiran meets primary and all secondary endpoints

* Alnylam Pharmaceuticals Inc - “overall safety profile of patisiran was encouraging”‍​

* Alnylam Pharmaceuticals- all five other secondary endpoints demonstrated statistically significant favorable differences in patisiran arm versus placebo ‍​

* Alnylam Pharmaceuticals - in trial, at 18 months, mean change from baseline in MNIS+7 was significantly lower in patisiran group versus placebo‍​ Source text for Eikon: Further company coverage:

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