Alnylam and FDA Agree on Primary Endpoint for Lumasiran in Primary Hyperoxaluria Type 1 Study

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), announced on 5/3/18 that the Company has reached alignment with the U.S. Food and Drug Administration (FDA) on a pivotal study design for lumasiran, an investigational RNAi therapeutic for the treatment of primary hyperoxaluria type 1 (PH1). The Company and the FDA have aligned on a primary endpoint for the pivotal study based on reduction of urinary oxalate at six months, a biomarker directly linked to the pathophysiology of PH1 and known to be well correlated with disease progression.