cerliponase alfa

FDA Drug Profile — Brineura

Drug Details

Generic Name
cerliponase alfa
Brand Names
Brineura
Application Number
BLA761052
Sponsor
BioMarin International Limited
NDC Codes
3
Dosage Forms
INJECTION, SOLUTION, KIT
Routes
N/A
Active Ingredients
CERLIPONASE ALFA

Indications and Usage

1 INDICATIONS AND USAGE BRINEURA is indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. BRINEURA is a hydrolytic lysosomal N-terminal tripeptidyl peptidase indicated to slow the loss of ambulation in pediatric patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency. ( 1 )