Alnylam Reports Results of Vutrisiran in P-III HELIOS-A Study for Patients with hATTR Amyloidosis with Polyneuropathy

January 8, 2021 Auto Bot Alnylam, Clinical Trials, P-III, patients, reports, results, Study 0

Shots:

  • The P-III HELIOS-A study assessing vutrisiran (25mg, SC, once every 3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in 164 patients in a ratio (3:1) with hATTR amyloidosis with polyneuropathy
  • The study met its 1EPs & 2EPs i.e. change from baseline in the mNIS+7 @9mos. & changes in QoL assessed by Norfolk QoL-DN and gait speed assessed by the timed 10-MWT respectively. Additionally, therapy showed improvements in the 9mos. exploratory cardiac endpoint of NT-proBNP
  • The company plans to submit NDA to the US FDA in H1’21, following the regulatory filing in Brazil and Japan. Moreover, Alnylam intends to submit MAA in the EU on obtaining the results of 18mos. analysis, anticipated in late 2021

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

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