Posted by Michael Wonder on 16 Sep 2016
BioMarin announces EMA validation of Brineura (cerliponase alfa) marketing authorization application for treatment of CLN2 disease, a form of Batten disease
15 September 2016 - CHMP opinion and EU decision expected in Q3 2017.
BioMarin announced today that the EMA validated the Marketing Authorisation Application (MAA) for Brineura (cerliponase alfa) to treat children with CLN2 disease, a form of Batten disease.
Validation of the MAA confirms that the submission is accepted and starts the formal review process by the EMA's CHMP.
