Search Results for "therapeutic"
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For more information about our FDA-approved therapies, please see the Full Prescribing Information:
Lumasiran: ILLUMINATE-B Study Overview
Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-B, a study evaluating the efficacy and safety of lumasiran in infants and children less than 6 years old with PH1.
Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-B, a study evaluating the efficacy and safety of lumasiran in infants and children less than 6 years old with PH1.
Patisiran: Post-Orthotopic Liver Transplant
Standard response letter on patisiran and the open-label phase 3b study evaluating the efficacy, safety and PK of patisiran in patients with hATTR who had polyneuropathy progression post-OLT. Additional summaries of case reports are also included.
Standard response letter on patisiran and the open-label phase 3b study evaluating the efficacy, safety and PK of patisiran in patients with hATTR who had polyneuropathy progression post-OLT. Additional summaries of case reports are also included.
ATTR Disease Management
This deck highlights management and monitoring of patients with ATTR.
This deck highlights management and monitoring of patients with ATTR.
Lumasiran: ILLUMINATE-C Study Overview
Standard response letter on lumasiran phase 3 clinical study ILLUMINATE-C, a study evaluating the efficacy and safety of lumasiran in infants to adult patients with PH1 and advanced kidney disease.
Standard response letter on lumasiran phase 3 clinical study ILLUMINATE-C, a study evaluating the efficacy and safety of lumasiran in infants to adult patients with PH1 and advanced kidney disease.
Givosiran: ENVISION Study 36-Month Results
Standard response letter on givosiran and the 36-month results of the ENVISION study, a phase 3 study evaluating the efficacy and safety of givosiran in patients with a documented diagnosis of AHP.
Standard response letter on givosiran and the 36-month results of the ENVISION study, a phase 3 study evaluating the efficacy and safety of givosiran in patients with a documented diagnosis of AHP.
Zilebesiran: KARDIA-2 Study
Standard response letter on zilebesiran and the KARDIA-2 study, a phase 2 study evaluating the efficacy and safety of zilebesiran as add-on therapy in patients with hypertension not adequately controlled by a standard-of-care antihypertensive medication including diuretic (indapamide), CCB (amlodipine), or ARB (olmesartan).
Standard response letter on zilebesiran and the KARDIA-2 study, a phase 2 study evaluating the efficacy and safety of zilebesiran as add-on therapy in patients with hypertension not adequately controlled by a standard-of-care antihypertensive medication including diuretic (indapamide), CCB (amlodipine), or ARB (olmesartan).
Lumasiran: Use in Kidney Transplantation
Standard response letter on the use of lumasiran in patients who have had an isolated kidney transplant.
Standard response letter on the use of lumasiran in patients who have had an isolated kidney transplant.
Lumasiran: Kidney Related Outcomes
Standard response letter on lumasiran and kidney-related measures such as eGFR, kidney stone event rates, and nephrocalcinosis across clinical trials.
Standard response letter on lumasiran and kidney-related measures such as eGFR, kidney stone event rates, and nephrocalcinosis across clinical trials.
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.
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.
