Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Vutrisiran: Injection Site Reactions
Standard response letter on vutrisiran and injection site reactions.
Standard response letter on vutrisiran and injection site reactions.
Patisiran: Use in Patients with Wild-Type ATTR
Standard response letter on patisiran and its use in patients with wild-type transthyretin amyloidosis in the APOLLO and APOLLO-B studies.
Standard response letter on patisiran and its use in patients with wild-type transthyretin amyloidosis in the APOLLO and APOLLO-B studies.
Patisiran: APOLLO-B Study
Standard response letter on patisiran and the APOLLO-B study, a study evaluating the efficacy and safety of patisiran in patients with ATTR with cardiomyopathy, including both hATTR and wtATTR.
Standard response letter on patisiran and the APOLLO-B study, a study evaluating the efficacy and safety of patisiran in patients with ATTR with cardiomyopathy, including both hATTR and wtATTR.
Givosiran: Mechanism of Action and Chemical Properties
Standard response letter on the mechanism of action and chemical properties of givosiran.
Standard response letter on the mechanism of action and chemical properties of givosiran.
Patisiran: Technetium Uptake by Scintigraphy
Standard response letter on patisiran and technetium scintigraphy data assessed in a subset of patients from the APOLLO-B study.
Standard response letter on patisiran and technetium scintigraphy data assessed in a subset of patients from the APOLLO-B study.
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: Concomitant Use with Tafamidis
Standard response letter on vutrisiran and concomitant use with tafamidis.
Standard response letter on vutrisiran and concomitant use with tafamidis.
Lumasiran: Pediatric Weight Based Dosing Increase Regimen
Standard response letter on lumasiran and protocol for dosing in pediatric patients who experience weight increases.
Standard response letter on lumasiran and protocol for dosing in pediatric patients who experience weight increases.
