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Alnylam's Vutrisiran Receives the US FDA's Fast Track Designation to Treat Polyneuropathy of hATTR Amyloidosis

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Alnylam's Vutrisiran Receives the US FDA's Fast Track Designation to Treat Polyneuropathy of hATTR Amyloidosis

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  • The US FDA has granted FT designation vutrisiran for treating polyneuropathy of hATTR amyloidosis in adults. The designation allows Alnylam to submit NDA for vutrisiran
  • The P-I study assessing Vutrisiran (quarterly dosing with low-volume- SC) demonstrated a reduction in the burden of care for the disease. The safety & efficacy of the therapy are being evaluated ongoing HELIOS-A and HELIOS-B P-III clinical studies with the anticipated P-III HELIOS-A results in H1’21
  • Vutrisiran (SC) is an investigational- RNAi therapeutic in development for the treatment of ATTR amyloidosis- which encompasses both hereditary (hATTR) and wild-type (wtATTR) amyloidosis

Click here ­to­ read full press release/ article | Ref: Alnylam | Image: Alnylam


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