Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Patisiran: Transitioning from Inotersen
Standard response letter on transitioning from an antisense oligonucleotide to patisiran.
Standard response letter on transitioning from an antisense oligonucleotide to patisiran.
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.
Zilebesiran: KARDIA-2 Study
Standard response letter on zilebesiran and the KARDIA-2 study, a phase 2 study evaluating the efficacy and safety of zilebesiran as add-on therapy in patients with hypertension not adequately controlled by a standard-of-care antihypertensive medication including diuretic (indapamide), CCB (amlodipine), or ARB (olmesartan).
Standard response letter on zilebesiran and the KARDIA-2 study, a phase 2 study evaluating the efficacy and safety of zilebesiran as add-on therapy in patients with hypertension not adequately controlled by a standard-of-care antihypertensive medication including diuretic (indapamide), CCB (amlodipine), or ARB (olmesartan).
Givosiran: Post-Dose Monitoring
Standard response letter on givosiran and monitoring post-injection.
Standard response letter on givosiran and monitoring post-injection.
Vutrisiran: Survival and Mortality
Standard response letter on mortality and survival data from the HELIOS studies of vutrisiran.
Standard response letter on mortality and survival data from the HELIOS studies of vutrisiran.
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.
Lumasiran: Clinical Pharmacology
Standard Response Letter on lumasiran and its pharmacokinetic and pharmacodynamic properties.
Standard Response Letter on lumasiran and its pharmacokinetic and pharmacodynamic properties.