Halozyme Therapeutics, Inc. (NASDAQ: HALO), a $6.5 billion biotech, announced today that argenx has received European Commission (EC) approval for VYVGART 1000mg (efgartigimod alfa) with ENHANZE technology for subcutaneous injection in the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP).
The approved treatment, developed using Halozyme’s proprietary recombinant human hyaluronidase enzyme (rHuPH20), is indicated for CIDP patients who have previously received corticosteroids or immunoglobulins.
According to the company, VYVGART represents the first targeted IgG Fc-antibody fragment for CIDP and introduces the first novel mechanism of action for this condition in more than three decades.
The EC approval was based on results from the ADHERE clinical trial, which the company describes as the largest study of CIDP patients to date. The approval extends to all 27 European Union member states, plus Iceland, Norway, and Liechtenstein.
The subcutaneous formulation can be administered by patients, caregivers, or healthcare professionals and is available as a vial or prefilled syringe.
"This marks another milestone in our partnership with argenx and the expansion of access to Europe is another catalyst supporting our growth," said Dr. Helen Torley, president and chief executive officer of Halozyme, in a press release statement. The company’s strong execution is reflected in its impressive 25.7% revenue growth and industry-leading 76.2% gross profit margin over the last twelve months.
Halozyme’s ENHANZE drug delivery technology is designed to facilitate subcutaneous delivery of injected drugs, potentially improving patient experience through rapid delivery and reduced treatment burden.
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