Brineura Approval History
FDA Approved: Yes (First approved April 27, 2017)
Brand name: Brineura
Generic name: cerliponase alfa
Dosage form: Injection
Company: BioMarin Pharmaceutical Inc.
Treatment for: CLN2 Disease
Brineura (cerliponase alfa) is an enzyme replacement therapy for the restoration of tripeptidyl peptidase-1 (TPP1) enzyme activity in patients with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), or TPP1 deficiency, a form of Batten disease.
Development History and FDA Approval Process for Brineura
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