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 […]Read More
Shots: The MAA submission to ANVISA is based on P-III APOLLO study results assessing Onpattro in patients hATTR amyloidosis with polyneuropathy, evaluating its safety and efficacy and the results are also published in The New England Journal of Medicine in July 5, 2018 Alnylam’s Onpattro has also received ANIVSA’s Priority Review which is granted to […]Read More
Shots: The approval is based on P-III NEURO-TTR study trial assessing Tegsedi vs PBO in 172 patients in ratio (2:1) with hATTR amyloidosis with symptoms of polyneuropathy The study resulted in effective results in measures of neuropathy and QoL while measuring with a Neuropathy Impairment Score +7 (mNIS+7) & Norfolk QOL-DN total score with 80% […]Read More
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