Search Results for "therapeutic"

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

Impact of Patisiran on Health Status and Quality of Life in Patients with Transthyretin Cardiac Amyloidosis

Patient Demographics and clinical characteristics at enrolment in ELEVATE, an international registry of Acute Hepatic Porphyria

Effect of Patisiran Treatment in Patients with hATTR Amyloidosis with Cardiomyopathy and Polyneuropathy: Post-hoc Analysis of the APOLLO-B Study

Enrollment Characteristics and Real-World Insights Into Disease Burden and Givosiran Treatment in Patients With Acute Hepatic Porphyria in the ELEVATE Registry

Lumasiran for Primary Hyperoxaluria Type 1: Analysis of Urinary Oxalate and Estimated Glomerular Filtration Rate Over Time in Patients by Genotype

Evaluation of Disease Progression in Patients with ATTR Amyloidosis with Cardiomyopathy Following Treatment with Patisiran: Post hoc Analysis of the APOLLO-B Study

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.

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.

Lumasiran: Injection Site Reactions

Standard response letter on the incidence and recommendations for management of injection site reactions.

Givosiran: Elevations in Blood Homocysteine

Standard response letter on givosiran and elevations in blood homocysteine.

Givosiran: Pregnancy and Lactation

Standard response letter on givosiran and its use in pregnant or lactating patients.

Patisiran: Vitamin A Levels

Standard response letter on patisiran and vitamin A levels.

Givosiran: Use in Pediatric Patients

Standard response letter on givosiran and pediatric use. This medical information response contains clinical data from the ENVISION study, ELEVATE registry, and published case reports.

Patisiran: Serum Transthyretin Levels

Standard response letter on patisiran and changes in serum TTR levels observed in the Phase 2 OLE, APOLLO, APOLLO-B, and HELIOS-A studies.

Dimension analysis of EQ-5D in patients with acute hepatic porphyria categorized by annualized attack rate to assess any relationship with symptoms occurring between attack

Lumasiran: ILLUMINATE-A Study Overview

Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-A, a study evaluating the efficacy and safety of lumasiran in adults and children who are 6 years of age or older with PH1.

Patisiran: Infusion-related Reactions

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

Patisiran: Use in Patients with Renal Impairment

Standard response letter on patisiran and use in patients with renal impairment. The letter contains information from a post-hoc analysis in patients with ATTR and CKD across the APOLLO, APOLLO-B, Phase 3b Post-OLT, Phase 2 OLE, and Global OLE studies, as well as relevant information from a global safety database.

Givosiran: Use in Patients with Prior History of Hemin Prophylaxis

Standard response letter on the use of givosiran in patients with a prior history of hemin prophylaxis from the ENVISION study.

Long-Term Efficacy and Safety in the Phase 3 ILLUMINATE-B Trial of Lumasiran for Primary Hyperoxaluria Type 1 in Infants and Young Children

Kidney Function and Isolated Kidney Transplant Outcomes in Primary Hyperoxaluria Type 1 Treated Long-term With Lumasiran

Diagnosing PH1 Infographic

This infographic discusses the clinical and demographic presentation of a PH1 patient and how to assess for PH1 diagnosis

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.

Efficacy and Safety of Vutrisiran and Patisiran

Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.

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 "therapeutic"

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.

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.

Lumasiran: Injection Site Reactions Standard response letter on the incidence and recommendations for management of injection site reactions.

Givosiran: Elevations in Blood Homocysteine Standard response letter on givosiran and elevations in blood homocysteine.

Givosiran: Pregnancy and Lactation Standard response letter on givosiran and its use in pregnant or lactating patients.

Patisiran: Vitamin A Levels Standard response letter on patisiran and vitamin A levels.

Givosiran: Use in Pediatric Patients Standard response letter on givosiran and pediatric use. This medical information response contains clinical data from the ENVISION study, ELEVATE registry, and published case reports.

Patisiran: Serum Transthyretin Levels Standard response letter on patisiran and changes in serum TTR levels observed in the Phase 2 OLE, APOLLO, APOLLO-B, and HELIOS-A studies.

Lumasiran: ILLUMINATE-A Study Overview Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-A, a study evaluating the efficacy and safety of lumasiran in adults and children who are 6 years of age or older with PH1.

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

Givosiran: Use in Patients with Prior History of Hemin Prophylaxis Standard response letter on the use of givosiran in patients with a prior history of hemin prophylaxis from the ENVISION study.

Diagnosing PH1 Infographic This infographic discusses the clinical and demographic presentation of a PH1 patient and how to assess for PH1 diagnosis

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.

Efficacy and Safety of Vutrisiran and Patisiran Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.