3 May 2016 - BioMarin today announced that the EMA has granted BioMarin's request for accelerated assessment for the planned cerliponase alfa Marketing Authorization Application (MAA).

Accelerated assessments are granted on the grounds that a product may satisfy an unmet medical need and is of major interest from the point of view of therapeutic innovation and public health. Accelerated assessment has the potential to shorten EMA's review procedure. However, at any time during the MAA assessment, the EMA may decide to continue the assessment under standard assessment timelines, and most applications that initially qualify for accelerated assessment are ultimately reviewed on a standard timeline.

The company expects to submit the cerliponase alfa MAA to the EMA and the Biologics License Application to the US FDA by mid-year. If the cerliponase alfa MAA is accepted by the EMA, then an opinion from the CHMP is anticipated in the first quarter of 2017, and, if positive, a decision from the European Commission could be received in the first half of 2017.

In the US, BioMarin is seeking to shorten the regulatory review time by requesting priority review. The FDA will evaluate this request following submission of the planned Biologics License Application. Cerliponase alfa has been granted orphan drug designation by the FDA and EMA and breakthrough therapy designation by the FDA.

For more details, go to: http://investors.bmrn.com/releasedetail.cfm?ReleaseID=968719