Search Results for "therapeutic"
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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).
ASPIRE: Amyloidosis Industry Collaborative
ASPIRE: Amyloidosis Industry Collaborative convenes leading companies to address some of the most urgent issues faced by the amyloidosis community. Through partnership we are driven to shift the discourse and demonstrate what can be done when leaders work together on behalf of rare disease patients.
ASPIRE aims to accelerate progress in the areas of diagnosis, care, and addressing health disparities through collaborative project design and shared resources, arriving at solutions that address common challenges and unmet need.
ASPIRE: Amyloidosis Industry Collaborative convenes leading companies to address some of the most urgent issues faced by the amyloidosis community. Through partnership we are driven to shift the discourse and demonstrate what can be done when leaders work together on behalf of rare disease patients. ASPIRE aims to accelerate progress in the areas of diagnosis, care, and addressing health disparities through collaborative project design and shared resources, arriving at solutions that address common challenges and unmet need.
Zilebesiran: Phase 2 Studies
Standard response letter on zilebesiran and the phase 2 studies: KARDIA-1, KARDIA-2, and KARDIA-3.
Standard response letter on zilebesiran and the phase 2 studies: KARDIA-1, KARDIA-2, and KARDIA-3.
Nucresiran: Phase 1 Study
Standard response letter on the phase 1 study of nucresiran.
Standard response letter on the phase 1 study of nucresiran.
Lumasiran: Dosing Administration Window
Standard response letter on lumasiran and the dosing administration window in the ILLUMINATE-A, ILLUMINATE-B, and ILLUMINATE-C studies.
Standard response letter on lumasiran and the dosing administration window in the ILLUMINATE-A, ILLUMINATE-B, and ILLUMINATE-C studies.
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.
Patisiran: Premedications
Standard response letter on patisiran and premedications during the APOLLO, Global OLE, and APOLLO-B studies.
Standard response letter on patisiran and premedications during the APOLLO, Global OLE, and APOLLO-B studies.
Givosiran: Hepatic Effects
Standard response letter on hepatic effects observed with the use of givosiran.
Standard response letter on hepatic effects observed with the use of givosiran.
Zilebesiran: Phase 1 Study Overview
Standard response letter on the phase 1 study of zilebesiran, a study evaluating the safety, PK , PD, as well as exploratory antihypertensive efficacy of zilebesiran in patients with hypertension.
Standard response letter on the phase 1 study of zilebesiran, a study evaluating the safety, PK , PD, as well as exploratory antihypertensive efficacy of zilebesiran in patients with hypertension.
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.
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.
Givosiran: Use in Patients with Pre-Existing Hepatic Impairment
Standard response letter on givosiran and use in patients with pre-existing kidney impairment from the ENVISION study.
Standard response letter on givosiran and use in patients with pre-existing kidney impairment from the ENVISION study.
