Brineura Approval History

• FDA approved: Yes (First approved April 27th, 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

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.