| 2017-04-21 13:30:43|
BMRN 13:30 04/21 04/21/17
BioMarin announces positive CHMP opinion in Europe for Brineura
BioMarin Pharmaceutical announced that the Committee for Medicinal Products for Human Use, or CHMP, the scientific committee of the European Medicines Agency, has adopted a positive opinion for the company's Marketing Authorization Application for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease, a form of Batten disease, which is also known as tripeptidyl peptidase 1 deficiency. The CHMP's recommendation is now referred to the European Commission, which is expected to render its final decision by the second quarter of 2017. "The EC typically adheres to the recommendation of the CHMP, but is not obligated to do so. If approved by the EC, BioMarin will receive marketing authorization for Brineura in all 28 countries of the European Union, Norway, Iceland and Liechtenstein," the company stated.