Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) announced that argenx's VYVDURA (efgartigimod alfa and hyaluronidase-qvfc), which is co-formulated with Halozyme's ENHANZE^® drug delivery technology, was granted regulatory approval by Japan's Ministry of Health, Labour and Welfare (MHLW) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVDURA was approved for CIDP as a once weekly 30-to-90 second subcutaneous injection, which can be self-administered at home, and is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP.

"We are pleased that VYVDURA, with our innovative ENHANZE drug delivery technology, is now approved for two indications in Japan, enabling greater flexibility and optionality for generalized myasthenia gravis and CIDP patients," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to VYVDURA being a new treatment option for an even broader number of patients in Japan."

The MHLW 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 VYVDURA, 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. Ninety-nine percent of trial participants elected to participate in the ADHERE+ open-label extension. The safety results were generally consistent with the known safety profile of VYVDURA in previous clinical studies and real-world use.

VYVDURA was also approved by the MHLW for manufacturing and marketing in January 2024 and launched in April 2024 for the treatment of generalized myasthenia gravis (gMG). In March 2024, VYVDURA was designated as an Orphan Drug for the treatment of CIDP by the MHLW.