Research & Development
Alnylam Pharmaceuticals starts FDA New Drug Application rolling submission for lumasiran
14 January 2020 -

United States-based Alnylam Pharmaceuticals has started a rolling submission of its New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for its lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase intended for the treatment of primary hyperoxaluria type 1 (PH1), it was reported yesterday.

The rolling submission enables completed sections of an NDA to be reviewed by the USFDA on an ongoing basis. The company has submitted the non-clinical components to the FDA and expects to submit the remaining components in early 2020.

The company has also received a paediatric rare disease designation from the FDA for lumasiran for the treatment of PH1.



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