Search Results for "hATTR"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Vutrisiran: Use in Patients with Renal Impairment
Standard response letter on vutrisiran and use in patients with renal impairment.
Standard response letter on vutrisiran and use in patients with renal impairment.
Transition between Patisiran and Vutrisiran
Standard response letter on transitioning between patisiran and vutrisiran therapy.
Standard response letter on transitioning between patisiran and vutrisiran therapy.
Vutrisiran: HELIOS-A Study
Standard response letter on vutrisiran and results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with the polyneuropathy of hATTR.
Standard response letter on vutrisiran and results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with the polyneuropathy of hATTR.
Vutrisiran: Post-Hoc Analysis of HELIOS-A Results by Baseline NIS Quartile
Standard response letter summarizing the results of a post-hoc analysis of the HELIOS-A study, conducted to evaluate the impact of baseline polyneuropathy severity, as measured by NIS, on response to vutrisiran treatment.
Standard response letter summarizing the results of a post-hoc analysis of the HELIOS-A study, conducted to evaluate the impact of baseline polyneuropathy severity, as measured by NIS, on response to vutrisiran treatment.
Vutrisiran: Randomized Treatment Extension Period of the HELIOS-A Study
Standard response letter on vutrisiran and results from a 9-month analysis of the randomized treatment extension period of HELIOS-A.
Standard response letter on vutrisiran and results from a 9-month analysis of the randomized treatment extension period of HELIOS-A.
Vutrisiran: Arthralgia
Standard response letter on vutrisiran and the adverse event of arthralgia.
Standard response letter on vutrisiran and the adverse event of arthralgia.
Vutrisiran: Dyspnea
Standard response letter on vutrisiran and the adverse event of dyspnea.
Standard response letter on vutrisiran and the adverse event of dyspnea.
Efficacy and Safety of Vutrisiran and Patisiran
Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.
Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.
Patisiran: Use in Patients with Renal Impairment
Standard response letter on patisiran and use in patients with renal impairment. The letter contains information from a post-hoc analysis in patients with ATTR and CKD across the APOLLO, APOLLO-B, Phase 3b Post-OLT, Phase 2 OLE, and Global OLE studies, as well as relevant information from a global safety database.
Standard response letter on patisiran and use in patients with renal impairment. The letter contains information from a post-hoc analysis in patients with ATTR and CKD across the APOLLO, APOLLO-B, Phase 3b Post-OLT, Phase 2 OLE, and Global OLE studies, as well as relevant information from a global safety database.
Patisiran: Cardiac Results from the APOLLO Study
Standard response letter on patisiran and the exploratory cardiac results in the APOLLO study, a study evaluating the efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.
Standard response letter on patisiran and the exploratory cardiac results in the APOLLO study, a study evaluating the efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.
