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# FDA, Alnylam Agree on Lumasiran Study
- URL: https://www.fdaweb.com/fda-alnylam-agree-on-lumasiran-study/
- Published: 2018-05-03T12:00:00.000Z
- Updated: 2026-09-15T00:02:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141360

FDA has reached an agreement with Alnylam Pharmaceuticals on elements of a Phase 3 study for its lumasiran, an investigational RNAi therapeutic for treating primary hyperoxaluria type 1 (PH1). The company [says](http://www.marketwatch.com/story/alnylam-achieves-alignment-with-fda-on-accelerated-development-path-for-lumasiran-an-investigational-rnai-therapeutic-for-the-treatment-of-primary-hyperoxaluria-type-1-ph1-2018-05-03?ref=fdaweb.com) it and the agency have agreed on a study size of about 25 patients with PH1 and a primary endpoint based on reduction of urinary oxalate at six months, a biomarker directly linked to PH1 pathophysiology and known to be well correlated with disease progression. The company says that with these agreements it is on track to start the study in mid-2018, report topline results in 2019, and potentially submit an NDA in early 2020\. FDA recently granted lumasiran breakthrough designation.