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Halozyme Announces argenx Received Positive CHMP Opinion for VYVGART® (efgartigimod alfa) Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
European Commission (EC) decision on marketing authorization application expected within approximately two months SAN DIEGO, April 28, 2025 /PRNewswire/ --
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"European Commission (EC) decision on marketing authorization application expected within approximately two months\nSAN DIEGO, April 28, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20) for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.\nThe SC injection of VYVGART® is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional.\nVYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the first novel mechanism of action for CIDP treatment in more than 30 years.\n\"We are delighted that the subcutaneous injection of VYVGART® co-formulated with our ENHANZE drug delivery technology, has been recommended for approval in the European Union. The positive CHMP opinion moves argenx closer to offering patients throughout Europe a groundbreaking new treatment option. We are proud to support argenx achieve their vision of developing innovative, targeted treatments for patients with rare and severe autoimmune diseases,\" said Dr. Helen Torley, president and chief executive officer of Halozyme.\nThe CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. For more information on the CHMP recommendation, and the ADHERE study and its findings, please view argenx's press release issued on April 28, 2025.\nThe EC is expected to make a decision following CHMP recommendation and the decision will apply to all 27 European Union Member States, and also to Iceland, Norway and Liechtenstein.\nAbout Halozyme\nHalozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology wi...