On July 19, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that Janssen-Cilag International NV (Janssen) has submitted an extension application to the European Medicines Agency (EMA) for the subcutaneous delivery of DARZALEX (daratumumab) for patients with multiple myeloma (Press release, Halozyme, JUL 19, 2019, View Source [SID1234537628]).
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"We are pleased that Janssen’s filing follows quickly after its filing last week of a Biologics License Application (BLA) with the U.S. Food and Drug Administration," said Dr. Helen Torley, President and CEO. "We are particularly excited that, pending approval by the EMA, a greater number of patients with multiple myeloma may soon have a new therapeutic option that offers the potential of DARZALEX with a shorter administration time."
Janssen’s submission follows the announcement of positive results from its Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX in comparison to intravenous DARZALEX in patients with relapsed and refractory multiple myeloma. 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.
About 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 are administered intravenously may instead be delivered subcutaneously. ENHANZE may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.