Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Vutrisiran: Use in Patients with Wild-Type ATTR
Standard response letter on the use of vutrisiran in patients with wild-type ATTR.
Standard response letter on the use of vutrisiran in patients with wild-type ATTR.
Patisiran: Pregnancy and Lactation
Standard response letter on patisiran and pregnancy & lactation. This letter contains information on preclinical toxicology studies and the APOLLO, APOLLO-B, and HELIOS-A studies.
Standard response letter on patisiran and pregnancy & lactation. This letter contains information on preclinical toxicology studies and the APOLLO, APOLLO-B, and HELIOS-A studies.
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: Post-Orthotopic Liver Transplant
Standard response letter on the exclusion of patients with a history of liver transplant from the HELIOS studies of vutrisiran.
Standard response letter on the exclusion of patients with a history of liver transplant from the HELIOS studies of vutrisiran.
Mivelsiran: cAPPricorn-1 Study
Standard response letter on mivelsiran and the phase 2 cAPPricorn-1 study in patients with sporadic or hereditary CAA.
Standard response letter on mivelsiran and the phase 2 cAPPricorn-1 study in patients with sporadic or hereditary CAA.
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.
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.
Lumasiran: Temperature Cycling and Stability
Standard response letter on the temperature cycling and stability of lumasiran. This letter contains stability data assessed from a batch of lumasiran drug product stored under long term conditions and thermal and cyclic stress.
Standard response letter on the temperature cycling and stability of lumasiran. This letter contains stability data assessed from a batch of lumasiran drug product stored under long term conditions and thermal and cyclic stress.
Vutrisiran: Safety Results from HELIOS-B
Standard response letter on vutrisiran and safety information from the HELIOS-B study.
Standard response letter on vutrisiran and safety information from the HELIOS-B study.