Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
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.
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).
Vutrisiran: Storage and Stability
Standard response letter on vutrisiran and storage and stability. The letter contains information on product stability when stored at a range of temperatures, photostability, and thermal cycling.
Standard response letter on vutrisiran and storage and stability. The letter contains information on product stability when stored at a range of temperatures, photostability, and thermal cycling.
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.
Patisiran: Half-Life and Duration of Effect
Standard response letter on the half-life and duration of effect of patisiran.
Standard response letter on the half-life and duration of effect of patisiran.
Vutrisiran: Autonomic Symptom Assessment
Standard Response Letter on vutrisiran and autonomic outcomes from the HELIOS-A study.
Standard Response Letter on vutrisiran and autonomic outcomes from the HELIOS-A study.
Patisiran: Cardiac Results from the Global OLE Study
Standard response letter on patisiran and cardiac results in the APOLLO OLE study, a study evaluating the long-term efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.
Standard response letter on patisiran and cardiac results in the APOLLO OLE study, a study evaluating the long-term efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.
Givosiran: Elevations in Blood Homocysteine
Standard response letter on givosiran and elevations in blood homocysteine.
Standard response letter on givosiran and elevations in blood homocysteine.
Vutrisiran: Immunogenicity
Standard response letter on vutrisiran and anti-drug antibodies. This letter contains information on the percentage of patients in vutrisiran clinical studies who tested positive for anti-drug antibodies.
Standard response letter on vutrisiran and anti-drug antibodies. This letter contains information on the percentage of patients in vutrisiran clinical studies who tested positive for anti-drug antibodies.