Posted by Michael Wonder on 22 Apr 2017
BioMarin receives positive CHMP opinion in Europe for Brineura (cerliponase alfa) for first treatment of CLN2 disease, a form of Batten disease and ultra-rare and fatal brain disorder in children
21 April 2017 - One of the first therapies to receive positive CHMP opinion using new accelerated assessment process decision on marketing authorisation application expected Q2 for potential first treatment for any form of Batten disease.
BioMarin announced today that the CHMP, the scientific committee of the EMA, has adopted a positive opinion for the company's marketing authorisation application for Brineura (cerliponase alfa) 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 (EC), 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 authorisation for Brineura in all 28 countries of the European Union, Norway, Iceland and Liechtenstein.
