Janssen Announced Submission of Extension Application to EMA for DARZALEX®

| By | EMA, Janssen, New Drug Application

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of an extension application to the European Medicines Agency (EMA) for subcutaneous (under the skin) use of DARZALEX® (daratumumab) for the treatment of patients with multiple myeloma.

This subcutaneous formulation of daratumumab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme’s ENHANZE® drug delivery technology]. Daratumumab is currently only approved for intravenous (IV) use.

“This new formulation is an example of our unwavering commitment to pursue innovative treatment options to support people living with multiple myeloma,”

said Dr Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag.

“Importantly, subcutaneous daratumumab demonstrated comparable efficacy with the existing IV formulation, reduced the rate of infusion-related reactions and significantly shortened the time it takes for patients to receive treatment, from several hours to approximately five minutes.”

The submission is supported by two studies, the Phase 2 PLEIADES (MMY2040) study and the Phase 3 COLUMBA (MMY3012) study recently presented at the 24th European Hematology Association (EHA) Congress, and at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting where the data were selected for the Best of ASCO 2019 Meetings, which highlight practice-changing science and leading research in oncology.

“Janssen has an extensive heritage in multiple myeloma and we are committed to developing innovative approaches to minimise the treatment burden for patients with multiple myeloma,”

said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC.

“We look forward to working with the EMA in its review of the data supporting this application.”

Janssen has also submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the new daratumumab subcutaneous formulation.