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Genmab Announces CHMP Grants Accelerated Assessment for Daratumumab for Double Refractory Multiple Myeloma


Genmab A/S (OTC: GNMSF) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment to the Marketing Authorization Application (MAA) for daratumumab. The MAA is for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma. The MAA was submitted to the EMA on September 9, 2015 by Janssen-Cilag International NV. In August 2012, Genmab granted Janssen Biotech (NYSE: JNJ), Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

The CHMP grants accelerated assessment when a medicinal product is expected to be of major public health interest particularly from the point of view of therapeutic innovation.

"Patients with multiple myeloma, particularly those who have exhausted all approved treatment options, are waiting for new medicines to treat this incurable disease. An accelerated approval optimizes the potential for daratumumab to provide a new therapy for this patient group more rapidly than under a standard review time," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The MAA submission includes data from the

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Posted-In: News FDA Press Releases


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