Alnylam’s Full Lumasiran Dataset Seen As Confirming Approvability

Building on data first reported last December, lumasiran appears on pace for approval by the December 2020 action date, but Dicerna still may show its drug is best-in-class.

Alnylam appears on track for its third RNAi therapeutic approval

Alnylam Pharmaceuticals Inc. reported detailed results from the Phase III ILLUMINATE-A study of lumasiran in primary hyperoxaluria type 1 (PH1) on 7 June, and while analysts are saying the RNA interference (RNAi) candidate is clearly approvable in the ultra-orphan indication, they also think the data leave room for competing drugs being developed for the disease.

As Alnylam presented the full ILLUMINATE-A dataset at the European Renal Association-European Dialysis and Transplant Association virtual conference, the biotech said its new drug application (NDA) for lumasiran has been accepted by the US Food and Drug Administration for priority review with an action date of 3 December

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