Search Results for "amyloidosis"

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Patisiran: Management of Infusion-Related Reactions

Standard response letter on the management of infusion-related reactions in patisiran clinical studies.

Patisiran: Autonomic Outcomes

Standard Response Letter on patisiran and autonomic outcomes from the APOLLO study.

Patisiran: Observation Period After Infusion

Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.

Vutrisiran: Cardiac Magnetic Resonance Imaging

Standard response letter on vutrisiran and data from patients who underwent serial CMR and participated in HELIOS-B.

Vutrisiran: Dosage & Administration Schedule Used in Phase 3 Studies

Standard response letter on the dosing schedules of vutrisiran used in the HELIOS-A and HELIOS-B studies.

Patisiran: Blood Brain Barrier

Standard response letter containing pre-clinical data on the tissue distribution of patisiran.

Vutrisiran: Cardiac Results from the HELIOS-A Study

Standard response letter on vutrisiran and exploratory cardiac results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with hATTR-PN.

Vutrisiran: HELIOS-B Study

Standard response letter on vutrisiran and the HELIOS-B study, a phase 3 study evaluating the efficacy and safety of vutrisiran in patients with the cardiomyopathy of ATTR, including both hATTR and wtATTR.

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.

Vutrisiran: Impact on Thyroid Function

Standard response letter on vutrisiran and thyroid function.

Patisiran: Dosing Schedule

Standard response letter on patisiran and the dosing schedule used in clinical trials.

Givosiran: Mechanism of Action and Chemical Properties

Standard response letter on the mechanism of action and chemical properties of givosiran.

Vutrisiran: Use in Patients Undergoing Dialysis

Standard response letter on the use of vutrisiran in patients undergoing dialysis.

Vutrisiran: Orthostatic Hypotension

Standard response letter on the quantitative effect of vutrisiran on orthostatic hypotension in the HELIOS-A study, assessed using the postural blood pressure component of mNIS+7.

Vutrisiran: Pregnancy & Lactation

Standard response letter on vutrisiran and pregnancy & lactation. This letter contains information on preclinical toxicology studies and the HELIOS-A and HELIOS-B studies.

Amyloidosis Project ECHO

Virtual interactive clinic offers quarterly 1-hour sessions focused on AL (light chain) and ATTR (transthyretin) amyloidosis, two underrecognized but increasingly manageable causes of heart failure and multisystem disease.

Vutrisiran: HELIOS-B OLE

Standard response letter on vutrisiran and the open-label extension period of the HELIOS-B study, a phase 3 study evaluating the efficacy and safety of vutrisiran in patients with the cardiomyopathy of ATTR, including both hATTR and wtATTR.

Vutrisiran: Analysis of Quality of Life and Physical Function Outcomes in HELIOS-A

Standard response letter on the analysis of quality of life, physical function, and nutritional status outcomes with treatment of vutrisiran in the HELIOS-A study.

Vutrisiran: Use in Patients with Renal Impairment

Standard response letter on vutrisiran and use in patients with renal impairment.

Vutrisiran: Concomitant Use with Tafamidis

Standard response letter on vutrisiran and concomitant use with tafamidis.

Vutrisiran: Survival and Mortality

Standard response letter on mortality and survival data from the HELIOS-B study of vutrisiran.

Vutrisiran: Cardiac Biomarkers in HELIOS-B

Standard response letter on exploratory cardiac biomarker analyses in HELIOS-B.

For further information regarding your request, please connect with us by reaching out to your local Medical Science Liaison or contacting our Medical Information team.

Search Results for "amyloidosis"

Patisiran: Management of Infusion-Related Reactions Standard response letter on the management of infusion-related reactions in patisiran clinical studies.

Patisiran: Autonomic Outcomes Standard Response Letter on patisiran and autonomic outcomes from the APOLLO study.

Patisiran: Observation Period After Infusion Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.

Vutrisiran: Cardiac Magnetic Resonance Imaging Standard response letter on vutrisiran and data from patients who underwent serial CMR and participated in HELIOS-B.

Vutrisiran: Dosage & Administration Schedule Used in Phase 3 Studies Standard response letter on the dosing schedules of vutrisiran used in the HELIOS-A and HELIOS-B studies.

Patisiran: Blood Brain Barrier Standard response letter containing pre-clinical data on the tissue distribution of patisiran.

Vutrisiran: Cardiac Results from the HELIOS-A Study Standard response letter on vutrisiran and exploratory cardiac results from the HELIOS-A study evaluating efficacy and safety of vutrisiran in patients with hATTR-PN.

Vutrisiran: HELIOS-B Study Standard response letter on vutrisiran and the HELIOS-B study, a phase 3 study evaluating the efficacy and safety of vutrisiran in patients with the cardiomyopathy of ATTR, including both hATTR and wtATTR.

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.

Vutrisiran: Impact on Thyroid Function Standard response letter on vutrisiran and thyroid function.

Patisiran: Dosing Schedule Standard response letter on patisiran and the dosing schedule used in clinical trials.

Givosiran: Mechanism of Action and Chemical Properties Standard response letter on the mechanism of action and chemical properties of givosiran.

Vutrisiran: Use in Patients Undergoing Dialysis Standard response letter on the use of vutrisiran in patients undergoing dialysis.

Vutrisiran: Orthostatic Hypotension Standard response letter on the quantitative effect of vutrisiran on orthostatic hypotension in the HELIOS-A study, assessed using the postural blood pressure component of mNIS+7.

Vutrisiran: Pregnancy & Lactation Standard response letter on vutrisiran and pregnancy & lactation. This letter contains information on preclinical toxicology studies and the HELIOS-A and HELIOS-B studies.

Amyloidosis Project ECHO Virtual interactive clinic offers quarterly 1-hour sessions focused on AL (light chain) and ATTR (transthyretin) amyloidosis, two underrecognized but increasingly manageable causes of heart failure and multisystem disease.

Vutrisiran: HELIOS-B OLE Standard response letter on vutrisiran and the open-label extension period of the HELIOS-B study, a phase 3 study evaluating the efficacy and safety of vutrisiran in patients with the cardiomyopathy of ATTR, including both hATTR and wtATTR.

Vutrisiran: Analysis of Quality of Life and Physical Function Outcomes in HELIOS-A Standard response letter on the analysis of quality of life, physical function, and nutritional status outcomes with treatment of vutrisiran in the HELIOS-A study.

Vutrisiran: Use in Patients with Renal Impairment Standard response letter on vutrisiran and use in patients with renal impairment.

Vutrisiran: Concomitant Use with Tafamidis Standard response letter on vutrisiran and concomitant use with tafamidis.

Vutrisiran: Survival and Mortality Standard response letter on mortality and survival data from the HELIOS-B study of vutrisiran.

Vutrisiran: Cardiac Biomarkers in HELIOS-B Standard response letter on exploratory cardiac biomarker analyses in HELIOS-B.