Search Results for "therapeutic"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Givosiran: Renal Effects
Standard response letter on renal effects observed with the use of givosiran.
Standard response letter on renal effects observed with the use of givosiran.
NfL as a Biomarker in hATTR Amyloidosis Infographic.
Infographic companion to the article by Sato et al, "Neurofilament light chain as a biomarker for monitoring response to change in treatment in hereditary ATTR amyloidosis", published in the journal Amyloid, 2023.
Infographic companion to the article by Sato et al, "Neurofilament light chain as a biomarker for monitoring response to change in treatment in hereditary ATTR amyloidosis", published in the journal Amyloid, 2023.
Diagnosing AHP
AHP Diagnosis
AHP Diagnosis
N/A
Title: Add-On Treatment With Zilebesiran for Inadequately Controlled Hypertension:
The KARDIA-2 Randomized Clinical Trial
Publication Date: July 2025
Journal: JAMA
Authors: Akshay Desai, Adam Karns, Jolita Badariene, et al.
Title: Add-On Treatment With Zilebesiran for Inadequately Controlled Hypertension: The KARDIA-2 Randomized Clinical Trial Publication Date: July 2025 Journal: JAMA Authors: Akshay Desai, Adam Karns, Jolita Badariene, et al.
Mivelsiran: Phase 1 Study
Standard response letter on the phase 1 study of mivelsiran.
Standard response letter on the phase 1 study of mivelsiran.
Lumasiran: Mechanism of Action
Standard response letter on the mechanism of action of lumasiran.
Standard response letter on the mechanism of action of lumasiran.
Givosiran: Monthly Dosing Timeframe
Standard response letter on the monthly dosing administration and dosing window of givosiran in the ENVISION study.
Standard response letter on the monthly dosing administration and dosing window of givosiran in the ENVISION study.
Patisiran: Dosing Schedule
Standard response letter on patisiran and the dosing schedule used in clinical trials.
Standard response letter on patisiran and the dosing schedule used in clinical trials.
Zilebesiran: ZENITH Study
Standard response letter on zilebesiran and the ZENITH study, a phase 3 cardiovascular outcomes trial.
Standard response letter on zilebesiran and the ZENITH study, a phase 3 cardiovascular outcomes trial.
Givosiran: Use in Patients with Pre-Existing Renal Impairment
Standard response letter on the use of givosiran in patients with pre-existing renal impairment.
Standard response letter on the use of givosiran in patients with pre-existing renal impairment.
Patisiran: Autonomic Outcomes
Standard Response Letter on patisiran and autonomic outcomes from the APOLLO study.
Standard Response Letter on patisiran and autonomic outcomes from the APOLLO study.
Givosiran: Post-Dose Monitoring
Standard response letter on givosiran and monitoring post-injection.
Standard response letter on givosiran and monitoring post-injection.
Patisiran: Observation Period After Infusion
Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.
Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.
Patisiran: Orthostatic Hypotension
Standard response letter on the effect of patisiran on orthostatic hypotension in the APOLLO, Global OLE, and HELIOS-A studies.
Standard response letter on the effect of patisiran on orthostatic hypotension in the APOLLO, Global OLE, and HELIOS-A studies.
Patisiran: Management of Infusion-Related Reactions
Standard response letter on the management of infusion-related reactions in patisiran clinical studies.
Standard response letter on the management of infusion-related reactions in patisiran clinical studies.
Vutrisiran: Cross-Reactivity with Patisiran
Standard response letter on the cross-reactivity between vutrisiran and patisiran.
Standard response letter on the cross-reactivity between vutrisiran and patisiran.
Lumasiran: Dosing Regimen
Standard response letter on the dosing regimen of lumasiran.
Standard response letter on the dosing regimen of lumasiran.
Patisiran: Total Dilution Volume
Standard response letter on patisiran and total dilution volume. This letter contains information on a stability study and the APOLLO, APOLLO-B, and Global OLE studies.
Standard response letter on patisiran and total dilution volume. This letter contains information on a stability study and the APOLLO, APOLLO-B, and Global OLE studies.
Lumasiran Clinical Program Overview
This infographic details the lumasiran clinical program (including ILLUMINATE) which investigates the treatment of primary hyperoxaluria type 1 with lumasiran.
This infographic details the lumasiran clinical program (including ILLUMINATE) which investigates the treatment of primary hyperoxaluria type 1 with lumasiran.
HELIOS-B Plain Language Summary
This material is a short summary of HELIOS-B primary medical and scientific publications (including peer-reviewed medical journal articles and scientific conference presentations)
This material is a short summary of HELIOS-B primary medical and scientific publications (including peer-reviewed medical journal articles and scientific conference presentations)