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Halozyme Announces Janssen's Receipt Of CHMP Positive Opinion For DARZALEX® Subcutaneous Formulation Utilizing Halozyme's ENHANZE® Technology For Patients With Multiple Myeloma
- Subcutaneous formulation can be administered in approximately five minutes, compared to multi-hour intravenous infusions - SAN DIEGO, April 30, 2020
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"- Subcutaneous formulation can be administered in approximately five minutes, compared to multi-hour intravenous infusions -\n\n\nSAN DIEGO, April 30, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen-Cilag International NV (Janssen) received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX® (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings. The CHMP's Positive Opinion for daratumumab SC formulation applies to all current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients. \nThe DARZALEX® SC formulation utilizes Halozyme's ENHANZE® drug delivery technology and reduces the treatment time from several hours to approximately five minutes with comparable efficacy to intravenous DARZALEX® and lower rates of infusion-related reactions.\n\"We are excited that a subcutaneous formulation of DARZALEX® is one step closer to transforming the treatment experience for multiple myeloma patients and physicians in the European Union,\" said Dr. Helen Torley, president and chief executive officer. \"Once available, multiple myeloma patients may benefit from a shorter infusion time when compared with a multi-hour intravenous infusion.\"\nThe CHMP opinion is supported by data from Janssen's Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX® in comparison to intravenous DARZALEX® in patients with relapsed and refractory multiple myeloma, and the Phase 2 PLEIADES study. In the COLUMBA study, subcutaneous DARZALEX®, using ENHANZE® drug delivery technology, was found to be non-inferior to intravenous DARZALEX® with regard to the co-primary endpoints of overall response rate and maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.\nAbout ENHANZE® Technology Halozyme's proprietary ENHANZE® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that ar...