SAN DIEGO, CA — Halozyme Therapeutics, Inc. announced that argenx received U.S. Food and Drug Administration (FDA) approval for VYVGART® Hytrulo co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP).

VYVGART® Hytrulo for CIDP is FDA-approved as a once weekly 30-to-90 second subcutaneous (SC) injection. This approval also represents the second FDA-approved indication for VYVGART® Hytrulo with ENHANZE®.

"With this approval, CIDP patients in the U.S. will have access to the first novel mechanism of action to treat CIDP in 30 years, which lessens the burden of treatment as a 30 to 90 second weekly SC injection," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to continuing to support argenx with our ENHANZE technology that has enabled improved treatment options that provide meaningful benefits for patients and healthcare providers."

The FDA approval is based on the ADHERE study, the largest clinical trial to date studying CIDP. In the ADHERE study, 69% (221/322) of patients treated with VYVGART® Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. 99% of trial participants elected to participate in the ADHERE open-label extension. The safety results were generally consistent with the known safety profile of VYVGART® in previous clinical studies and real-world use.

VYVGART® Hytrulo is also approved in the U.S. for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.