Search Results for "Alnylam"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Lumasiran: ILLUMINATE-C Study Overview
Standard response letter on lumasiran phase 3 clinical study ILLUMINATE-C, a study evaluated the efficacy and safety of lumasiran in infants to adult patients with PH1 and advanced kidney disease.
Standard response letter on lumasiran phase 3 clinical study ILLUMINATE-C, a study evaluated the efficacy and safety of lumasiran in infants to adult patients with PH1 and advanced kidney disease.
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.
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.
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.
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.
Givosiran: Latex Content
Standard response letter on the latex content of givosiran vial.
Standard response letter on the latex content of givosiran vial.
