Search Results for "amyloidosis"
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Patisiran: Use in Patients with hATTR Amyloidosis with Cardiomyopathy and Polyneuropathy
Standard response letter on the use of patisiran in patients with hATTR and mixed phenotype from the APOLLO-B study.
Standard response letter on the use of patisiran in patients with hATTR and mixed phenotype from the APOLLO-B study.
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).
