HALO - J&J's Janssen division wins European approval of Darzalex subcutaneous formulation
Michael Vi/iStock Editorial via Getty Images Johnson & Johnson's (JNJ) Janssen division received two European Commission ("EC") marketing authorizations for Darzalex SC, a subcutaneous formulation of Darzalex (daratumumab). The first is for Darzalex SC in combination with Velcade (bortezomib), cyclophosphamide, and dexamethasone for the newly diagnosed systemic light-chain amyloidosis. The second is for Darzalex SC in combination with Pomalyst (pomalidomide) and dexamethasone as a second- or third-line therapy for multiple myeloma. In August 2012, Genmab (GMAB) granted Janssen an exclusive worldwide license to develop, manufacture and commercialize Darzalex. Darzalex SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), a drug delivery technology from Halozyme (HALO). J&J shares are down 7 cents to $163.77 in afternoon trading.
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J&J's Janssen division wins European approval of Darzalex subcutaneous formulation