Search Results for "therapeutic"

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Exploratory Biomarker Analyses from HELIOS-B, A Phase 3 Study of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy

HELIOS-B: Primary results from a phase 3 study of vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy

Realizing the therapeutic potential of rapid knockdown of transthyretin via RNA interference in transthyretin amyloidosis

Vutrisiran Treatment in Patients with Transthyretin Amyloidosis with Cardiomyopathy

This asset represents the HELIOS-B primary results, published in the New England Journal of Medicine, in slide deck form.

Patisiran Treatment for ATTR Cardiac Amyloidosis: 18-Month Results of the Phase 3 APOLLO-B Study

Effects of Patisiran, an RNA Interference Therapeutic, on Cardiac Parameters in Patients With Hereditary Transthyretin-Mediated Amyloidosis

Association of Patisiran, an RNA Interference Therapeutic, With Regional Left Ventricular Myocardial Strain in Hereditary Transthyretin Amyloidosis: The APOLLO Study

Zilebesiran: Phase 1 Study Overview

Standard response letter on the phase 1 study of zilebesiran, a study evaluating the safety, PK , PD, as well as exploratory antihypertensive efficacy of zilebesiran in patients with hypertension.

Patisiran: Pregnancy and Lactation

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

Transition between Patisiran and Vutrisiran

Standard response letter on transitioning between patisiran and vutrisiran therapy.

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.

Vutrisiran: Impact on Thyroid Function

Standard response letter on vutrisiran and thyroid function.

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.

Mivelsiran: cAPPricorn-1 Study

Standard response letter on mivelsiran and the phase 2 cAPPricorn-1 study in patients with sporadic or hereditary CAA

Givosiran: Mechanism of Action and Chemical Properties

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

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.

Lumasiran: Pediatric Weight Based Dosing Increase Regimen

Standard response letter on lumasiran and protocol for dosing in pediatric patients who experience weight increases.

Lumasiran: Pregnancy and Lactation

Standard response letter on lumasiran and pregnancy and lactation in the Phase 2 OLE and Phase 3 ILLUMINATE studies.

ATTR Amyloidosis Disease State Handout

This handout provides an overview of ATTR manifestations and the diagnostic tools that can be used to assess their presentation.

Givosiran: Anaphylactic Reactions and Hypersensitivity

Standard response letter on givosiran and hypersensitivity, including anaphylactic reactions, observed.

Zilebesiran: KARDIA-3 Study

Standard response letter on zilebesiran and the KARDIA-3 study, an ongoing phase 2 study evaluating the efficacy and safety of zilebesiran in patients with high CV risk and hypertension that is not adequately controlled with at least 2 standard-of-care antihypertensives.

Small Interfering RNA Targeting Amyloid-Beta Precursor Protein Reduces Alzheimer’s Disease Pathology in 5xFAD Mice and Abrogates Behavior Changes in Early Intervention Paradigm

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.

Patisiran: Immunogenicity

Standard response letter on patisiran and the percentage of patients in patisiran clinical studies who tested positive for anti-drug antibodies.

Givosiran: Injection Site Reactions

Standard response letter on givosiran and injection site reactions during the phase 1, phase 1/2 open-label extension, and phase 3 ENVISION studies.

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Search Results for "therapeutic"

Exploratory Biomarker Analyses from HELIOS-B, A Phase 3 Study of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy

HELIOS-B: Primary results from a phase 3 study of vutrisiran in patients with transthyretin amyloidosis with cardiomyopathy

Realizing the therapeutic potential of rapid knockdown of transthyretin via RNA interference in transthyretin amyloidosis

Vutrisiran Treatment in Patients with Transthyretin Amyloidosis with Cardiomyopathy This asset represents the HELIOS-B primary results, published in the New England Journal of Medicine, in slide deck form.

Patisiran Treatment for ATTR Cardiac Amyloidosis: 18-Month Results of the Phase 3 APOLLO-B Study

Effects of Patisiran, an RNA Interference Therapeutic, on Cardiac Parameters in Patients With Hereditary Transthyretin-Mediated Amyloidosis

Association of Patisiran, an RNA Interference Therapeutic, With Regional Left Ventricular Myocardial Strain in Hereditary Transthyretin Amyloidosis: The APOLLO Study

Zilebesiran: Phase 1 Study Overview Standard response letter on the phase 1 study of zilebesiran, a study evaluating the safety, PK , PD, as well as exploratory antihypertensive efficacy of zilebesiran in patients with hypertension.

Patisiran: Pregnancy and Lactation Standard response letter on patisiran and pregnancy & lactation. This letter contains information on preclinical toxicology studies and the APOLLO, APOLLO-B, and HELIOS-A studies.

Transition between Patisiran and Vutrisiran Standard response letter on transitioning between patisiran and vutrisiran therapy.

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.

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

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.

Mivelsiran: cAPPricorn-1 Study Standard response letter on mivelsiran and the phase 2 cAPPricorn-1 study in patients with sporadic or hereditary CAA

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

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.

Lumasiran: Pediatric Weight Based Dosing Increase Regimen Standard response letter on lumasiran and protocol for dosing in pediatric patients who experience weight increases.

Lumasiran: Pregnancy and Lactation Standard response letter on lumasiran and pregnancy and lactation in the Phase 2 OLE and Phase 3 ILLUMINATE studies.

ATTR Amyloidosis Disease State Handout This handout provides an overview of ATTR manifestations and the diagnostic tools that can be used to assess their presentation.

Givosiran: Anaphylactic Reactions and Hypersensitivity Standard response letter on givosiran and hypersensitivity, including anaphylactic reactions, observed.

Zilebesiran: KARDIA-3 Study Standard response letter on zilebesiran and the KARDIA-3 study, an ongoing phase 2 study evaluating the efficacy and safety of zilebesiran in patients with high CV risk and hypertension that is not adequately controlled with at least 2 standard-of-care antihypertensives.