Stemline announces receipt of EMA validation for Elzonris MAA

Stemline announced that the European Medicines Agency, or EMA, has completed its validation of the marketing authorization application, or MAA, for Elzonris. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. Stemline submitted the MAA earlier this month seeking approval of Elzonris for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, or BPDCN. In November 2018, the MAA was granted accelerated assessment. Under European Union legislation, a medicinal product of major public health interest may be reviewed under an accelerated assessment procedure. Accelerated assessment can significantly reduce the timeframe for the EMA Committee for Medicinal Products for Human Use, or CHMP, to review an MAA.

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