VYVDURA Approved in Japan for CIDP

Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced that VYVDURA (efgartigimod alfa and hyaluronidase-qvfc), co-developed with Halozyme’s proprietary ENHANZE® drug delivery technology, has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. This once-weekly subcutaneous injection, which can be self-administered at home in just 30 to 90 seconds, is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP.

A Milestone for CIDP Patients

The approval expands VYVDURA's reach in Japan, where it was previously approved for generalized myasthenia gravis (gMG) and marks a significant step in CIDP treatment. Dr. Helen Torley, CEO of Halozyme, stated:
"The approval of VYVDURA, enabled by our innovative ENHANZE technology, offers greater flexibility and convenience to patients with CIDP and gMG. We are excited to see this therapy provide meaningful benefits to a broader patient population in Japan."

Clinical Validation from the ADHERE Study

The approval is based on results from the ADHERE Study, the largest clinical trial conducted for CIDP. Key findings include:

• 69% of patients (221 out of 322) treated with VYVDURA showed clinical improvements in mobility, function, and strength.
• A 61% reduction in relapse risk compared to placebo (HR: 0.39, 95% CI: 0.25–0.61; p<0.0001).
• High retention: 99% of participants opted to continue in the ADHERE+ open-label extension study.
• Safety outcomes were consistent with previous clinical studies and real-world data.

Key Milestones and Orphan Drug Designation

• VYVDURA was granted Orphan Drug Designation for CIDP in March 2024 by the MHLW, recognizing its potential to address an unmet medical need.
• The therapy was approved for manufacturing and marketing in January 2024 and launched in April 2024 for gMG treatment in Japan.

ENHANZE® Drug Delivery Technology

Halozyme’s ENHANZE® platform enhances drug delivery by enabling subcutaneous administration of therapies traditionally given intravenously. This breakthrough allows for shorter administration times, greater patient convenience, and the potential for at-home use, as seen with VYVDURA.

Impact for CIDP Patients

The approval of VYVDURA in Japan provides a novel treatment option for CIDP patients, allowing easier and faster administration while maintaining efficacy and safety. This milestone reflects Halozyme's ongoing commitment to improving patient outcomes through innovative drug delivery solutions.