Search Results for "hATTR"
Alnylam is committed to providing the healthcare community with balanced, accurate, and high-quality information about our science, therapeutic areas, and products.
More than one search term is recommended to yield the most relevant results. By searching, you confirm that your query is unsolicited.
For more information about our FDA-approved therapies, please see the Full Prescribing Information:
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: Post-Hoc Analysis of HELIOS-A Results by Baseline NIS Quartile
Standard response letter summarizing the results of a post-hoc analysis of the HELIOS-A study, conducted to evaluate the impact of baseline polyneuropathy severity, as measured by NIS, on response to vutrisiran treatment.
Standard response letter summarizing the results of a post-hoc analysis of the HELIOS-A study, conducted to evaluate the impact of baseline polyneuropathy severity, as measured by NIS, on response to vutrisiran treatment.
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.
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.
Vutrisiran: Dyspnea
Standard response letter on vutrisiran and the adverse event of dyspnea.
Standard response letter on vutrisiran and the adverse event of dyspnea.
Vutrisiran: Randomized Treatment Extension Period of the HELIOS-A Study
Standard response letter on vutrisiran and results from a 9-month analysis of the randomized treatment extension period of HELIOS-A.
Standard response letter on vutrisiran and results from a 9-month analysis of the randomized treatment extension period of HELIOS-A.
Phase 3 HELIOS-B Study Rationale
This slide deck highlights the Phase 3 trial design for HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy.
This slide deck highlights the Phase 3 trial design for HELIOS-B: A Study to Evaluate Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy.