Search Results for "diagnosis"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Givosiran: Post-Dose Monitoring
Standard response letter on givosiran and monitoring post-injection.
Standard response letter on givosiran and monitoring post-injection.
Lumasiran: Dialysis
Standard response letter on lumasiran and dialysis. This medical information response contains clinical data from the ILLUMINATE-C study and published case reports.
Standard response letter on lumasiran and dialysis. This medical information response contains clinical data from the ILLUMINATE-C study and published case reports.
Givosiran: Use in Patients Without an Identified Porphyria-Related Mutation
Standard response letter on the use of givosiran in patients with AHP without an identified porphyria-related genetic mutation.
Standard response letter on the use of givosiran in patients with AHP without an identified porphyria-related genetic mutation.
Givosiran: Pancreatitis
Standard response letter on givosiran and the adverse event of pancreatitis.
Standard response letter on givosiran and the adverse event of pancreatitis.
Long-term Assessment of Patients with AHP and AIP who were Not Attack-Free after 6-Months of Givosiran Treatment: A Post Hoc Subgroup Analysis of the Phase 3 ENVISION Study
An infographic depicting a post-hoc analysis of the ENVISION phase 3 study to understand the long-term clinical outcomes of patients who were not attack free after 6-months of givosiran treatment.
An infographic depicting a post-hoc analysis of the ENVISION phase 3 study to understand the long-term clinical outcomes of patients who were not attack free after 6-months of givosiran treatment.
Patisiran: Post-Orthotopic Liver Transplant
Standard response letter on patisiran and the open-label phase 3b study evaluating the efficacy, safety and PK of patisiran in patients with hATTR who had polyneuropathy progression post-OLT. Additional summaries of case reports are also included.
Standard response letter on patisiran and the open-label phase 3b study evaluating the efficacy, safety and PK of patisiran in patients with hATTR who had polyneuropathy progression post-OLT. Additional summaries of case reports are also included.
Lumasiran: Use in Kidney Transplantation
Standard response letter on the use of lumasiran in patients who have had an isolated kidney transplant.
Standard response letter on the use of lumasiran in patients who have had an isolated kidney transplant.
Patisiran: APOLLO Study Results
Standard response letter on patisiran and the APOLLO study, a phase 3 study evaluating the efficacy and safety of patisiran in patients with the hATTR-PN.
Standard response letter on patisiran and the APOLLO study, a phase 3 study evaluating the efficacy and safety of patisiran in patients with the hATTR-PN.
HELIOS-B Plain Language Summary
This material is a short summary of HELIOS-B primary medical and scientific publications (including peer-reviewed medical journal articles and scientific conference presentations)
This material is a short summary of HELIOS-B primary medical and scientific publications (including peer-reviewed medical journal articles and scientific conference presentations)
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.
Carpal Tunnel Release Surgery Handout
This handout provides an overview of two diagnostic algorithms for ATTR amyloidosis in patients with carpal tunnel syndrome.
This handout provides an overview of two diagnostic algorithms for ATTR amyloidosis in patients with carpal tunnel syndrome.
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.
BONAPH1DE: A Prospective, Observational Study of Patients with PH1
This infographic discusses the study design, objectives, key patient criteria, and planned countries for the BONAPH1DE observational study.
This infographic discusses the study design, objectives, key patient criteria, and planned countries for the BONAPH1DE observational study.
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.
RNAi Data Navigator: Focus on Vutrisiran
Use this interactive tool to learn more about ATTR, RNAi therapeutics, findings from the HELIOS B study in ATTR CM, findings from the HELIOS A study in hATTR PN, and Alnylam’s commitment to ATTR. HELIOS-B data include outcomes on survival, functional capacity, quality of life, CV events, exploratory measures of cardiac biomarkers, structure and function, post hoc extracardiac analyses, and safety. HELIOS-A data include outcomes on neuropathy impairment, quality of life, gait speed, nutritional status, disability, and safety. Navigate using the forward and backward controls. For optimal viewing, enter full-screen mode.
Use this interactive tool to learn more about ATTR, RNAi therapeutics, findings from the HELIOS B study in ATTR CM, findings from the HELIOS A study in hATTR PN, and Alnylam’s commitment to ATTR. HELIOS-B data include outcomes on survival, functional capacity, quality of life, CV events, exploratory measures of cardiac biomarkers, structure and function, post hoc extracardiac analyses, and safety. HELIOS-A data include outcomes on neuropathy impairment, quality of life, gait speed, nutritional status, disability, and safety. Navigate using the forward and backward controls. For optimal viewing, enter full-screen mode.
Givosiran: ENVISION Study 36-Month Results
Standard response letter on givosiran and the 36-month results of the ENVISION study, a phase 3 study evaluating the efficacy and safety of givosiran in patients with a documented diagnosis of AHP.
Standard response letter on givosiran and the 36-month results of the ENVISION study, a phase 3 study evaluating the efficacy and safety of givosiran in patients with a documented diagnosis of AHP.
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.
Givosiran: Monthly Dosing Timeframe
Standard response letter on the monthly dosing administration and dosing window of givosiran in the ENVISION study.
Standard response letter on the monthly dosing administration and dosing window of givosiran in the ENVISION study.
Vutrisiran: HELIOS-B Results by Baseline Heart Failure Disease Severity
Standard response letter on use of vutrisiran across baseline heart failure disease severity of patients enrolled in HELIOS-B.
Standard response letter on use of vutrisiran across baseline heart failure disease severity of patients enrolled in HELIOS-B.
Patisiran RWE in hATTR Amyloidosis
External title: Patisiran RWE in hATTR Amyloidosis
External description: This slide deck highlights real-world evidence (RWE) data on the use of patisiran in patients with hATTR amyloidosis, including patients with polyneuropathy, cardiomyopathy, solid organ transplant, concomitant treatment or treatment switch.
External title: Patisiran RWE in hATTR Amyloidosis External description: This slide deck highlights real-world evidence (RWE) data on the use of patisiran in patients with hATTR amyloidosis, including patients with polyneuropathy, cardiomyopathy, solid organ transplant, concomitant treatment or treatment switch.
Vutrisiran: HELIOS-A Study
Standard response letter on vutrisiran and results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with the polyneuropathy of hATTR.
Standard response letter on vutrisiran and results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with the polyneuropathy of hATTR.
Givosiran: Hemin Use
Standard response letter on givosiran and hemin use. This medical information response contains clinical data from the ENVISION study.
Standard response letter on givosiran and hemin use. This medical information response contains clinical data from the ENVISION study.