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# Alnylam Discontinues Revusiran Over Mortality Concerns
- URL: https://www.fdaweb.com/alnylam-discontinues-revusiran-over-mortality-concerns/
- Published: 2016-10-06T12:00:00.000Z
- Updated: 2026-09-14T21:38:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137010

Alnylam Pharmaceuticals has decided to discontinue developing revusiran, an investigational RNA interference therapeutic being developed for treating hereditary amyloid transthyretin amyloidosis with cardiomyopathy. The decision was based on a data monitoring committee (DMC) recommendation involving a Phase 3 study called ENDEAVOUR. The DMC did not find conclusive evidence for a drug-related neuropathy signal in the ENDEAVOUR trial, but informed the company that the benefit-risk profile for revusiran no longer supported continued dosing. Alnylam says it subsequently reviewed unblinded ENDEAVOUR data “which revealed an imbalance of mortality in the revusiran arm as compared to placebo.”