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US FDA grants priority review to Alnylam Pharmaceuticals' Givosiran.

M2 EQUITYBITES-August 7, 2019-US FDA grants priority review to Alnylam Pharmaceuticals' Givosiran

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The US Food and Drug Administration (FDA) has granted priority review to United States-based Alnylam Pharmaceuticals' investigational RNAi therapeutic, Givosiran, intended for the treatment of acute hepatic porphyria (AHP), it was reported yesterday.

The product is to be administered subcutaneously and is aimed at aminolevulinic acid synthase 1.

According to Alnylam, monthly administration of the investigational RNAi therapeutic can potentially decrease induced liver ALAS1 levels in a sustained manner by a significant extent. Owing to this capability, the investigational RNAi therapeutic can decrease neurotoxic heme intermediates, aminolevulinic acid and porphobilinogen, towards normal levels.

Givosiran has been set an action date of 4 February 2020 by the FDA under the Prescription Drug User Fee Act (PDUFA).

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Date:Aug 7, 2019
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