Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
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.
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.
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.
Givosiran: Latex Content
Standard response letter on the latex content of givosiran vial.
Standard response letter on the latex content of givosiran vial.
Lumasiran: ILLUMINATE-B Study Overview
Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-B, a study evaluating the efficacy and safety of lumasiran in infants and children less than 6 years old with PH1.
Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-B, a study evaluating the efficacy and safety of lumasiran in infants and children less than 6 years old with PH1.
