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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

DateArticle
Apr 27, 2017Approval FDA Approves Brineura (cerliponase alfa) for CLN2 Disease, a Form of Batten Disease
Sep  6, 2016BioMarin Announces Update to Brineura (cerliponase alfa) Program for Treatment of CLN2 Disease, a Form of Batten Disease
Jul 27, 2016FDA Accepts BLA for BioMarin’s Cerliponase Alfa for CLN2 Disease, Form of Batten Disease
Jan 12, 2015BioMarin Provides Preliminary Data From Ongoing Phase 1/2 Pivotal Study of BMN 190 for Treatment of CLN2 Disorder, a Form of Batten Disease

Further information

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