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Primary Results From APOLLO-B, A Phase 3 Study of Patisiran in Patients With Transthyretin-Mediated Amyloidosis With Cardiomyopathy
Alnylam Pharmaceuticals submitted a supplemental New Drug Application (sNDA) to the FDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis based on data from the APOLLO-B study. The FDA subsequently completed their review of the application in 2023 and issued a complete response letter (CRL).
Alnylam Pharmaceuticals submitted a supplemental New Drug Application (sNDA) to the FDA for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis based on data from the APOLLO-B study. The FDA subsequently completed their review of the application in 2023 and issued a complete response letter (CRL).
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.
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.
Patisiran: Temperature Excursions
Standard response letter on patisiran and temperature excursions. The letter includes information on the impact of temperature excursions not lower than -4°C and up to 40°C on the stability of patisiran.
Standard response letter on patisiran and temperature excursions. The letter includes information on the impact of temperature excursions not lower than -4°C and up to 40°C on the stability of patisiran.
Lumasiran: Stability in Prepared Syringe
Standard response letter on the stability of lumasiran in a prepared syringe.
Standard response letter on the stability of lumasiran in a prepared syringe.
Lumasiran: Temperature Cycling and Stability
Standard response letter on the temperature cycling and stability of lumasiran. This letter contains stability data assessed from a batch of lumasiran drug product stored under long term conditions and thermal and cyclic stress.
Standard response letter on the temperature cycling and stability of lumasiran. This letter contains stability data assessed from a batch of lumasiran drug product stored under long term conditions and thermal and cyclic stress.
Givosiran: Stability in Prepared Syringe
Standard response letter the stability of givosiran in a prepared syringe.
Standard response letter the stability of givosiran in a prepared syringe.
Lumasiran: Preparation and Administration
Standard response letter on the preparation and administration of lumasiran.
Standard response letter on the preparation and administration of lumasiran.
Vutrisiran: Warming Before Administration
Standard response letter on warming the syringe prior to administration of vutrisiran.
Standard response letter on warming the syringe prior to administration of vutrisiran.
Summary of RNA Interference
An overview of RNAi discovery, how RNAi works, and features of RNAi therapeutics
An overview of RNAi discovery, how RNAi works, and features of RNAi therapeutics
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.
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: Preparation and Administration
Standard response letter on the preparation and administration of patisiran.
Standard response letter on the preparation and administration of patisiran.
Patisiran: Filters for Preparation and Infusion
Standard response letter on filters used for the preparation and infusion of patisiran.
Standard response letter on filters used for the preparation and infusion of patisiran.
