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# Alnylam Rolling NDA for Lumasiran
- URL: https://www.fdaweb.com/alnylam-rolling-nda-for-lumasiran/
- Published: 2020-01-10T12:00:00.000Z
- Updated: 2026-09-14T15:58:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145823

Alnylam Pharmaceuticals has begun a rolling submission of its NDA for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for treating primary hyperoxaluria Type 1 (PH1). Specifically, the company submitted non-clinical components and it expects to submit the remaining components later this year 2020\. Alnylam also says it has been granted a pediatric rare disease designation from FDA for lumasiran. PH1 is a disease in which excessive oxalate production results in the deposition of calcium oxalate crystals in the kidneys and urinary tract and can lead to the formation of painful and recurrent kidney stones and nephrocalcinosis.