ARTICLE | Clinical News

Brineura cerliponase alfa regulatory update

September 12, 2016 7:00 AM UTC

BioMarin said FDA extended by 3 months to April 27, 2017, the PDUFA date for a BLA for Brineura cerliponase alfa to treat children with neuronal ceroid lipofuscinosis type 2 (CLN2) disease. The company said it submitted updated data requested by FDA from an ongoing extension study. BioMarin said the agency determined the submission qualified as a major amendment, resulting in the extended review. ...