Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biopharmaceutical company with over $1 billion in annual revenue and an impressive 76.5% gross margin, announced today that its collaborative partner, argenx, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. This recommendation is for the approval of VYVGART® 1000mg (efgartigimod alfa) by the European Commission (EC) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
VYVGART, developed with Halozyme’s ENHANZE® drug delivery technology, is a subcutaneous injection and the first targeted IgG Fc-antibody fragment designed for CIDP, marking the first novel mechanism of action in this therapeutic area in over three decades. The CHMP’s positive opinion is based on results from the ADHERE clinical trial, which is the largest study of CIDP patients to date.
Dr. Helen Torley, president and chief executive officer of Halozyme, expressed satisfaction with the CHMP’s recommendation, highlighting the potential for VYVGART to provide a new treatment option for CIDP patients across Europe. The EC decision, expected within approximately two months, will apply to all 27 EU Member States, as well as Iceland, Norway, and Liechtenstein.
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