FDA Approves BioMarin Pharma's BRINEURA For Children Under 3 Years With CLN2 Disease

(RTTNews) - BioMarin Pharmaceutical Inc. (BMRN) said that the U.S. Food and Drug Administration has approved the company's supplemental Biologics License Application (sBLA) for BRINEURA (cerliponase alfa) to slow the loss of ambulation in children of all ages with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency.

Previously, BRINEURA was indicated in symptomatic children 3 years of age and older with late infantile CLN2 disease.

The expanded indication now includes children of all ages with CLN2 disease, regardless of whether they are symptomatic or presymptomatic.

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