Janssen applies to US and EU for subcutaneous Darzalex
Using Halozyme’s Enhanze drug delivery technology, Janssen has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous delivery of Darzalex (daratumumab) for the treatment of multiple myeloma.
The application to the EMA follows on from a similar application to the US Food and Drug Administration (FDA) for a biologics license application (BLA) for the subcutaneous formulation of Darzalex.
Currently, the treatment is approved for intravenous (IV) use but the subcutaneous formulation offers certain advantages over this form of delivery, such as by reducing infusion-related reactions and by cutting down on the time needed to deliver the treatment from hours to approximately five minutes, the company suggested.
The application for the new delivery method was supported by data from Phase II and Phase III trials, which demonstrated non-inferiority.
Craig Tendler, VP of clinical development and global medical affairs, oncology, at Janssen, said, "The Darzalex subcutaneous formulation showed non-inferiority to the existing IV formulation, both as a monotherapy and in combination with common background therapies, while administered with a considerably shorter infusion time.”
Janssen has previously invested in developing innovative means of drug delivery, such as in its partnership to develop Felden Therapeutics’ intracellular delivery technology.
Halozyme’s tech pays off
Halozyme’s Enhanze drug delivery sees Darzalex co-formulated with recombinant human hyaluronidase PH20.
Genentech, a subsidiary of Roche, recently developed and received approval for a subcutaneous version of Herceptin (trastuzumab) through the use of Halozyme’s technology.
Previously, CEO of Halozyme, Helen Torley, told us that the subcutaneous version of Herceptin accounted for 60% of total volume of the drug sold.
Halozyme currently has licensing agreements with eight pharma and biotech companies for its technology.