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J&J unit seeks broadened approval of Darzalex in US, EU

Johnson & Johnson unit Janssen Pharmaceutica NV is seeking U.S. and European approval to broaden the existing marketing authorization for its multiple myeloma treatment Darzalex.

Janssen submitted an application to the U.S. Food and Drug Administration and the European Medicines Agency based on the results from a phase 3 study for using Darzalex in combination with bortezomib, melphalan and prednisone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

The EMA submission also triggered a $3 million milestone payment to Genmab A/S. Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize the drug in 2012.

Genmab recently received a $50 million in milestone payment in connection with its collaboration with J&J for Darzalex.