Search Results for "amyloidosis"

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For more information about our FDA-approved therapies, please see the Full Prescribing Information:

ATTR-CM HELIOS-B Data Summary

ATTR-CM HELIOS-B Data Summary deck provides a comprehensive overview of the HELIOS-B results. Also includes information on ATTR-CM and the MOA of RNAi therapeutics.

Patisiran: Cardiac Results from the Global OLE Study

Standard response letter on patisiran and cardiac results in the Global OLE study, a study evaluating the long-term efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.

Patisiran: Management of Extravasation

Standard response letter on patisiran and management of extravasation. This medical information response contains information on extravasation prevention guidelines that were provided to patisiran clinical trial sites.

Patisiran: Orthostatic Hypotension

Standard response letter on the effect of patisiran on orthostatic hypotension in the APOLLO, Global OLE, and HELIOS-A studies.

Patisiran: Premedications

Standard response letter on patisiran and premedications during the APOLLO, Global OLE, and APOLLO-B studies.

ATTR Disease Management

This deck highlights management and monitoring of patients with ATTR.

Patisiran: Infusion-related Reactions

Standard response letter on infusion-related reactions observed in patisiran clinical trials and post-marketing.

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.

ATTR Diagnostic and Staging Tools

This deck highlights diagnostic and staging tools for assessing patients with ATTR.

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.

Screening, Recognition, and Barriers to Diagnosis of ATTR

This deck highlights the screening, recognition, and barriers of diagnosis in ATTR.

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.

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"

ATTR-CM HELIOS-B Data Summary ATTR-CM HELIOS-B Data Summary deck provides a comprehensive overview of the HELIOS-B results. Also includes information on ATTR-CM and the MOA of RNAi therapeutics.

Patisiran: Cardiac Results from the Global OLE Study Standard response letter on patisiran and cardiac results in the Global OLE study, a study evaluating the long-term efficacy and safety of patisiran in patients with the polyneuropathy of hATTR.

Patisiran: Management of Extravasation Standard response letter on patisiran and management of extravasation. This medical information response contains information on extravasation prevention guidelines that were provided to patisiran clinical trial sites.

Patisiran: Orthostatic Hypotension Standard response letter on the effect of patisiran on orthostatic hypotension in the APOLLO, Global OLE, and HELIOS-A studies.

Patisiran: Premedications Standard response letter on patisiran and premedications during the APOLLO, Global OLE, and APOLLO-B studies.

ATTR Disease Management This deck highlights management and monitoring of patients with ATTR.

Patisiran: Infusion-related Reactions Standard response letter on infusion-related reactions observed in patisiran clinical trials and post-marketing.

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.

ATTR Diagnostic and Staging Tools This deck highlights diagnostic and staging tools for assessing patients with ATTR.

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.

Screening, Recognition, and Barriers to Diagnosis of ATTR This deck highlights the screening, recognition, and barriers of diagnosis in ATTR.

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.