Search Results for "therapeutic"

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

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

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

Lumasiran: Injection Site Reactions

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

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

Givosiran: Elevations in Blood Homocysteine

Standard response letter on givosiran and elevations in blood homocysteine.

Patisiran: Vitamin A Levels

Standard response letter on patisiran and vitamin A levels.

Givosiran: Pregnancy and Lactation

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

Hereditary transthyretin amyloidosis with polyneuropathy in the United States

Recommendations from a panel of experts for the diagnosis and treatment of hereditary transthyretin amyloidosis with polyneuropathy in the United States

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.

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

N/A

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.

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

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.

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.

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.

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 AHP Infographic

This infographic discusses the clinical and demographic presentation of an AHP patient and how to assess for AHP diagnosis.

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"

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.

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

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

Hereditary transthyretin amyloidosis with polyneuropathy in the United States Recommendations from a panel of experts for the diagnosis and treatment of hereditary transthyretin amyloidosis with polyneuropathy in the United States

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.

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

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.

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.

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

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.

Diagnosing AHP Infographic This infographic discusses the clinical and demographic presentation of an AHP patient and how to assess for AHP diagnosis.