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FDA extends review of BioMarin's Batten therapy

September 6, 2016 7:00 AM UTC

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) said FDA extended by three months its review of a BLA for Brineura cerliponase alfa ( BMN 190) to treat children with neuronal ceroid lipofuscinosis type 2 (CLN2), a form of Batten disease. BioMarin said its PDUFA date is now April 27, 2017.

The company said it submitted updated data from an ongoing extension study of the candidate upon FDA's request. The agency designated the new data as a major amendment to the application, but did not give its rationale for doing so, according to the company. ...