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Genmab Says FDA Okays Split Dosing Regimen For DARZALEX

Genmab A/S (GMXAY.PK) said that the U.S. Food and Drug Administration has approved a split dosing regimen for DARZALEX or daratumumab. The approval will be included in an update to the Prescribing Information in order to provide healthcare professionals the option to split the first infusion of DARZALEX over two consecutive days. The

supplemental Biologics License Application (sBLA) was submitted by Genmab's licensing partner, Janssen Biotech, Inc., in July, 2018. The split dosing option was previously approved in Europe by the European Commission in December 2018. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

The company noted that the approval was supported by data from the Phase Ib EQUULEUS (MMY1001) clinical trial, which demonstrated DARZALEX pharmacokinetics (PK) concentrations were comparable regardless of whether the first dose was administered as a split infusion or as a single first infusion in patients with multiple myeloma. The safety profile of DARZALEX was comparable when administered initially as either a split or a single dose.

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