A Multicenter, Multinational, Extension Study to Evaluate the Long-Term Efficacy and Safety of BMN 190 in Patients with CLN2 Disease
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 14 Aug 2017
At a glance
- Drugs Cerliponase alfa (Primary)
- Indications Neuronal ceroid lipofuscinosis
- Focus Adverse reactions; Therapeutic Use
- Sponsors BioMarin Pharmaceutical
- 01 Jun 2017 According to a BioMarin Pharmaceutical media release, the European Commission (EC) has granted marketing authorization for Brineura (cerliponase alfa), the first treatment approved in the European Union for the treatment of (CLN2). The MAA was based on this and another study.
- 08 Sep 2016 Updated long-term data from this trial will be presented at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2016 Annual Meeting, according to a BioMarin Pharmaceutical media release.
- 06 Sep 2016 According to a BioMarin Pharmaceutical media release, the company has provided an updated efficacy data from this extension study to US FDA, based on which the FDA has extended the PDUFA action date by three months to April 27, 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History