Search Results for "hATTR"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Givosiran: Hemin Use
Standard response letter on givosiran and hemin use. This medical information response contains clinical data from the ENVISION study.
Standard response letter on givosiran and hemin use. This medical information response contains clinical data from the ENVISION study.
Vutrisiran: Pain in Extremity
Standard response letter on vutrisiran and the adverse event of pain in extremity.
Standard response letter on vutrisiran and the adverse event of pain in extremity.
Primary Results From APOLLO-B, A Phase 3 Study of Patisiran in Patients With Transthyretin-Mediated Amyloidosis With Cardiomyopathy
Alnylam Pharmaceuticals submitted a supplemental New Drug Application (sNDA) to the FDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis based on data from the APOLLO-B study. The FDA subsequently completed their review of the application in 2023 and issued a complete response letter (CRL).
Alnylam Pharmaceuticals submitted a supplemental New Drug Application (sNDA) to the FDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis based on data from the APOLLO-B study. The FDA subsequently completed their review of the application in 2023 and issued a complete response letter (CRL).
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: HELIOS-A Study
Standard response letter on vutrisiran and results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with the polyneuropathy of hATTR.
Standard response letter on vutrisiran and results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with the polyneuropathy of hATTR.
