HALO - JNJ wins positive opinion in Europe for expanded use of DARZALEX

Janssen Pharmaceutica, a unit of Johnson & Johnson ([[JNJ]] +0.6%) has received two positive opinions from the European Medicines Agency ((EMA)) to broaden the current marketing authorization for DARZALEX (daratumumab) subcutaneous formulation ((SC)).One recommendation is for its use for adults with newly diagnosed systemic light chain ((AL)) amyloidosis as part of a drug combination containing cyclophosphamide, bortezomib, and dexamethasone (D-VCd).Second endorsement related to the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for a certain category of patients with multiple myeloma.The recommendations from EMA’s Committee for Medicinal Products for Human Use ((CHMP)) will next be reviewed by the European Commission ((EC)) before a potential approval in the region.Daratumumab subcutaneous SC uses ENHANZE technology developed by Halozyme Therapeutics ([[HALO]] -1.6%).In 2014, Halozyme licensed the technology to Janssen under a worldwide collaboration and license agreement that covered up to five targets.

For further details see:

JNJ wins positive opinion in Europe for expanded use of DARZALEX