Search Results for "ATTR-CM"

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Patisiran: Dosing Schedule

Standard response letter on patisiran and the dosing schedule used in clinical trials.

Vutrisiran: Post-Orthotopic Liver Transplant

Standard response letter on the exclusion of patients with a history of liver transplant from the HELIOS studies of vutrisiran.

Vutrisiran: Safety Results from HELIOS-B

Standard response letter on vutrisiran and safety information from the HELIOS-B study.

Vutrisiran: Dyspnea

Standard response letter on vutrisiran and the adverse event of dyspnea.

Patisiran: Hospitalization and Mortality

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

Patisiran: Observation Period After Infusion

Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.

Vutrisiran: Switch from TTR Stabilizers (Tafamidis, Acoramidis, or Diflunisal)

Standard response letter on switching from TTR stabilizers (tafamidis, acoramidis, or diflunisal) to vutrisiran.

Vutrisiran: Arthralgia

Standard response letter on vutrisiran and the adverse event of arthralgia.

Patisiran: Patients with Heart Transplant

Standard response letter on patisiran and use in patients with heart transplant.

Vutrisiran: Use in Patients with Hepatic Impairment

Standard response letter on vutrisiran and use in patients with hepatic impairment.

Hereditary ATTR Amyloidosis: A Closer Look at the V1221 Variant

V122I is the most common variant of hATTR amyloidosis in the United States and is most prevalent in patients of African American descent. Compared to other variants, patients with the V122I variant experience significant disease burden and poorer outcomes.

Vutrisiran: Cardiac Biomarkers in HELIOS-B

Standard response letter on exploratory cardiac biomarker analyses in HELIOS-B.

Patisiran: Management of Infusion-Related Reactions

Standard response letter on the management of infusion-related reactions in patisiran clinical studies.

Vutrisiran: Renal-Related Adverse Events

Standard response letter on vutrisiran and renal-related adverse events.

Vutrisiran: Vitamin A Levels

Standard response letter on vutrisiran and vitamin A levels, including information on supplementation.

Vutrisiran: HELIOS-B Study

Standard response letter on vutrisiran and 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.

Vutrisiran: Ocular Adverse Events

Standard response letter on vutrisiran and ocular adverse events in the HELIOS-A and HELIOS-B studies.

Vutrisiran: Changes in Serum TTR Levels

Standard response letter on vutrisiran and the changes in serum TTR levels during the HELIOS-A and HELIOS-B studies.

Vutrisiran: Injection Site Reactions

Standard response letter on vutrisiran and injection site reactions.

Patisiran: Total Dilution Volume

Standard response letter on patisiran and total dilution volume. This letter contains information on a stability study and the APOLLO, APOLLO-B, and Global OLE studies.

Patisiran: APOLLO-B OLE Study

Standard response letter on the APOLLO-B OLE study of patisiran.

Vutrisiran: Immunogenicity

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

Patisiran: Vitamin A Levels

Standard response letter on patisiran and vitamin A levels.

Vutrisiran: HELIOS-B Results by Baseline Heart Failure Disease Severity

Standard response letter on use of vutrisiran across baseline heart failure disease severity of patients enrolled in HELIOS-B.

Vutrisiran: Concomitant Use with Tafamidis

Standard response letter on vutrisiran and concomitant use with tafamidis.

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 "ATTR-CM"

Patisiran: Dosing Schedule Standard response letter on patisiran and the dosing schedule used in clinical trials.

Vutrisiran: Post-Orthotopic Liver Transplant Standard response letter on the exclusion of patients with a history of liver transplant from the HELIOS studies of vutrisiran.

Vutrisiran: Safety Results from HELIOS-B Standard response letter on vutrisiran and safety information from the HELIOS-B study.

Vutrisiran: Dyspnea Standard response letter on vutrisiran and the adverse event of dyspnea.

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

Patisiran: Observation Period After Infusion Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.

Vutrisiran: Switch from TTR Stabilizers (Tafamidis, Acoramidis, or Diflunisal) Standard response letter on switching from TTR stabilizers (tafamidis, acoramidis, or diflunisal) to vutrisiran.

Vutrisiran: Arthralgia Standard response letter on vutrisiran and the adverse event of arthralgia.

Patisiran: Patients with Heart Transplant Standard response letter on patisiran and use in patients with heart transplant.

Vutrisiran: Use in Patients with Hepatic Impairment Standard response letter on vutrisiran and use in patients with hepatic impairment.

Vutrisiran: Cardiac Biomarkers in HELIOS-B Standard response letter on exploratory cardiac biomarker analyses in HELIOS-B.

Patisiran: Management of Infusion-Related Reactions Standard response letter on the management of infusion-related reactions in patisiran clinical studies.

Vutrisiran: Renal-Related Adverse Events Standard response letter on vutrisiran and renal-related adverse events.

Vutrisiran: Vitamin A Levels Standard response letter on vutrisiran and vitamin A levels, including information on supplementation.

Vutrisiran: HELIOS-B Study Standard response letter on vutrisiran and 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.

Vutrisiran: Ocular Adverse Events Standard response letter on vutrisiran and ocular adverse events in the HELIOS-A and HELIOS-B studies.

Vutrisiran: Changes in Serum TTR Levels Standard response letter on vutrisiran and the changes in serum TTR levels during the HELIOS-A and HELIOS-B studies.

Vutrisiran: Injection Site Reactions Standard response letter on vutrisiran and injection site reactions.

Patisiran: Total Dilution Volume Standard response letter on patisiran and total dilution volume. This letter contains information on a stability study and the APOLLO, APOLLO-B, and Global OLE studies.

Patisiran: APOLLO-B OLE Study Standard response letter on the APOLLO-B OLE study of patisiran.

Vutrisiran: Immunogenicity Standard response letter on vutrisiran and anti-drug antibodies. This letter contains information on the percentage of patients in vutrisiran clinical studies who tested positive for anti-drug antibodies.

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

Vutrisiran: HELIOS-B Results by Baseline Heart Failure Disease Severity Standard response letter on use of vutrisiran across baseline heart failure disease severity of patients enrolled in HELIOS-B.

Vutrisiran: Concomitant Use with Tafamidis Standard response letter on vutrisiran and concomitant use with tafamidis.