Priority Review for BioMarin's Batten therapy

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said FDA accepted and granted Priority Review to a BLA for Brineura cerliponase alfa ( BMN 190) to treat children with neuronal ceroid lipofuscinosis type 2 (CLN2) disease, a form of Batten disease. Its PDUFA date is Jan. 27, 2017.

The company has also submitted an MAA to EMA for Brineura, a recombinant human tripeptidyl peptidase-1 ( TPP1) enzyme replacement therapy. Brineura has Orphan Drug and breakthrough therapy designations from FDA in the indication. ...