Search Results for "therapeutic"

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

Primary Results from APOLLO-B, A Phase 3 Study of Patisiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy

Gene Silencing Therapeutics in Cardiology: A Review Article

Patisiran, an RNAi Therapeutic, for Hereditary Transthyretin Amyloidosis

RNA interference in the era of nucleic acid therapeutics

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

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.

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.

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.

Patisiran: Product Stability

Standard response letter on patisiran and product stability. The letter includes information on the chemical, physical and photostability of the active substance, patisiran, and the diluted patisiran solution.

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.

Zilebesiran: KARDIA-1 Study

Standard response letter on zilebesiran and the KARDIA-1 study, an ongoing phase 2 study evaluating the efficacy and safety of zilebesiran dosing regimens for adults with mild to moderate hypertension.

Patisiran: Hospitalization and Mortality

Standard response letter on hospitalization and mortality data from patisiran clinical trials.

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Search Results for "therapeutic"

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.

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.

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.

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.

Patisiran: Product Stability Standard response letter on patisiran and product stability. The letter includes information on the chemical, physical and photostability of the active substance, patisiran, and the diluted patisiran solution.

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.

Zilebesiran: KARDIA-1 Study Standard response letter on zilebesiran and the KARDIA-1 study, an ongoing phase 2 study evaluating the efficacy and safety of zilebesiran dosing regimens for adults with mild to moderate hypertension.

Patisiran: Hospitalization and Mortality Standard response letter on hospitalization and mortality data from patisiran clinical trials.