Search Results for "ATTR-CM"
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Carpal Tunnel Release Surgery Handout
This handout provides an overview of two diagnostic algorithms for ATTR amyloidosis in patients with carpal tunnel syndrome.
This handout provides an overview of two diagnostic algorithms for ATTR amyloidosis in patients with carpal tunnel syndrome.
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.
Standard response letter on patisiran and changes in serum TTR levels observed in the Phase 2 OLE, APOLLO, APOLLO-B, 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.
Standard response letter on vutrisiran and data from patients who underwent serial CMR and participated in HELIOS-B.
Vutrisiran: Pharmacokinetic and Pharmacodynamic Properties
Standard Response Letter on vutrisiran and its pharmacokinetic and pharmacodynamic properties.
Standard Response Letter on vutrisiran and its pharmacokinetic and pharmacodynamic properties.
Vutrisiran: Results in Patients who had Progressed on Tafamidis in HELIOS B
Standard response letter on the use of vutrisiran in patients who had progressed on tafamidis at baseline in HELIOS-B.
Standard response letter on the use of vutrisiran in patients who had progressed on tafamidis at baseline in HELIOS-B.
Vutrisiran: Left Ventricular Ejection Fraction in HELIOS-B
Standard response letter on vutrisiran and LVEF in the HELIOS-B study.
Standard response letter on vutrisiran and LVEF in the HELIOS-B study.
Patisiran: Premedications
Standard response letter on patisiran and premedications during the APOLLO, Global OLE, and APOLLO-B studies.
Standard response letter on patisiran and premedications during the APOLLO, Global OLE, and APOLLO-B studies.
Vutrisiran: Survival and Mortality
Standard response letter on mortality and survival data from the HELIOS-B study of vutrisiran.
Standard response letter on mortality and survival data from the HELIOS-B study of vutrisiran.
Patisiran: Infusion-related Reactions
Standard response letter on infusion-related reactions observed in patisiran clinical trials and post-marketing.
Standard response letter on infusion-related reactions observed in patisiran clinical trials and post-marketing.
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.
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.
Standard response letter on transitioning between patisiran and vutrisiran therapy.
Vutrisiran: Use in Patients with Renal Impairment
Standard response letter on vutrisiran and use in patients with renal impairment.
Standard response letter on vutrisiran and use in patients with renal impairment.
Vutrisiran: Post Dose Monitoring
Standard response letter on vutrisiran and post-dose monitoring in the HELIOS-A and HELIOS-B studies.
Standard response letter on vutrisiran and post-dose monitoring in the HELIOS-A and HELIOS-B studies.
Vutrisiran: Transitioning from Antisense Oligonucleotide
Standard response letter on transitioning from an antisense oligonucleotide to vutrisiran.
Standard response letter on transitioning from an antisense oligonucleotide to vutrisiran.
Vutrisiran: Concomitant Use with Diflunisal
Standard response letter on the use of vutrisiran with concomitant diflunisal.
Standard response letter on the use of vutrisiran with concomitant diflunisal.
Patisiran: APOLLO-B Study
Standard response letter on patisiran and the APOLLO-B study, a study evaluating the efficacy and safety of patisiran in patients with ATTR with cardiomyopathy, including both hATTR and wtATTR.
Standard response letter on patisiran and the APOLLO-B study, a study evaluating the efficacy and safety of patisiran in patients with ATTR with cardiomyopathy, including both hATTR and wtATTR.
Vutrisiran: Use in Patients with Heart Transplant
Standard response letter on the use of vutrisiran in patients who have received a heart transplant.
Standard response letter on the use of vutrisiran in patients who have received a heart transplant.
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.
Standard response letter on the dosing schedules of vutrisiran used in the HELIOS-A and HELIOS-B studies.
Vutrisiran: HELIOS-B OLE
Standard response letter on vutrisiran and the open-label extension period of 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.
Standard response letter on vutrisiran and the open-label extension period of 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.
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.
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.
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.
Standard response letter on vutrisiran and pregnancy & lactation. This letter contains information on preclinical toxicology studies and the HELIOS-A and HELIOS-B studies.
Vutrisiran: Echocardiographic Assessments in HELIOS-B
Standard response letter on vutrisiran and exploratory echocardiographic assessments of cardiac structure and function in HELIOS-B.
Standard response letter on vutrisiran and exploratory echocardiographic assessments of cardiac structure and function in HELIOS-B.
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.
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.
