Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Givosiran: Timing of Dosing
Standard response letter on the timing of dosing of givosiran in the Phase 1 study.
Standard response letter on the timing of dosing of givosiran in the Phase 1 study.
Patisiran: Management of Extravasation
Standard response letter on patisiran and management of extravasation. This medical information response contains information on extravasation prevention guidelines that were provided to patisiran clinical trial sites.
Standard response letter on patisiran and management of extravasation. This medical information response contains information on extravasation prevention guidelines that were provided to patisiran clinical trial sites.
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.
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.
Vutrisiran: Analysis of Quality of Life and Physical Function Outcomes in HELIOS-A
Standard response letter on the analysis of quality of life, physical function, and nutritional status outcomes with treatment of vutrisiran in the HELIOS-A study.
Standard response letter on the analysis of quality of life, physical function, and nutritional status outcomes with treatment of vutrisiran in the HELIOS-A study.
Patisiran: Use in Patients Undergoing Dialysis
Standard response letter on patisiran and dialysis. This medical information response contains clinical pharmacology data about patisiran and safety data from the Phase 2 OLE, APOLLO, and Global OLE studies.
Standard response letter on patisiran and dialysis. This medical information response contains clinical pharmacology data about patisiran and safety data from the Phase 2 OLE, APOLLO, and Global OLE studies.
Vutrisiran: Arthralgia
Standard response letter on vutrisiran and the adverse event of arthralgia.
Standard response letter on vutrisiran and the adverse event of arthralgia.
Lumasiran: ILLUMINATE-A Study Overview
Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-A. This medical information response contains information on the 6-month double-blinded treatment period and through 36 months of the open-label extension.
Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-A. This medical information response contains information on the 6-month double-blinded treatment period and through 36 months of the open-label extension.
