Search Results for "ATTRv"
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Vutrisiran: Arthralgia
Standard response letter on vutrisiran and the adverse event of arthralgia.
Standard response letter on vutrisiran and the adverse event of arthralgia.
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: 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.
Efficacy and Safety of Vutrisiran and Patisiran
Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.
Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.
