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HALO Announces Janssen Submits Extension Application To European

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Fred Kadiddlehopper   Friday, 07/19/19 08:52:39 AM
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HALO Announces Janssen Submits Extension Application To European Medicines Agency For Subcutaneous Formulation Of DARZALE...

Friday 19 July 2019


SAN DIEGO, July 19, 2019 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today announced 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.

"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.

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