The Safety of Agalsidase Alfa Enzyme Replacement Therapy in Canadian Patients with Fabry Disease Following Implementation of a Bioreactor Process

ConclusionsLong-term treatment with bioreactor-produced agalsidase alfa animal component-free did not reveal new safety signals in this population of Canadian patients with Fabry disease. The treatment-emergent adverse event profile was consistent with the clinical manifestations of the disease and the known safety profile of roller bottle-produced agalsidase alfa.Clinical Trial RegistrationClinicalTrials.gov identifier NCT01298141.
Source: Drugs in R&D - Category: Drugs & Pharmacology Source Type: research