Posted by Michael Wonder on 21 Dec 2018
Janssen announces European Commission approval of Darzalex (daratumumab) split dosing regimen
20 December 2018 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission has granted marketing authorisation to provide healthcare professionals with the option to split the first infusion of Darzalex (daratumumab) over two consecutive days.
The decision was based on data from the Phase 1b EQUULEUS (MMY1001) clinical trial, which demonstrated daratumumab pharmacokinetics concentrations were comparable regardless of whether the first dose was administered as a split infusion or single first infusion in patients with multiple myeloma.1 The safety profile of daratumumab was comparable when administered initially as a split or single dose.1
The approval follows the Positive Opinion from the EMA CHMP on 19 November 2018.
