argenx (ARGX) FDA Announcement summary

Introduction and purpose

• FDA approved VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) on June 21, 2024, marking the first FcRn blocker and the first new mechanism of action for CIDP in over 30 years.

• The approval addresses a significant unmet need, as many CIDP patients are dissatisfied with current therapies and experience persistent symptoms.

Details of approval or decision

• VYVGART Hytrulo is the first and only targeted IgG Fc-antibody fragment therapy for CIDP, administered as a once-weekly, 30- to 90-second subcutaneous injection by a healthcare provider.

• The recommended dosage is 1,008 mg/11,200 units weekly.

• Approval was expedited using a priority review voucher, reducing review time from 10 to 6 months.

• VYVGART Hytrulo received a broad label for CIDP, with no restrictions based on prior therapy, allowing use across the treatment paradigm.

Impact on industry and stakeholders

• Approximately 12,000 adult CIDP patients in the U.S. are not well-managed with current options, representing a significant market opportunity.

• Annual net revenue per patient is projected at $450,000, with out-of-pocket costs expected to be similar to IVIG and MG.

• The commercial strategy focuses on empowering patients, supporting prescribers, engaging payers, and rapid adoption by neurologists.

• Patient support includes financial assistance, access navigation, and the My VYVGART Path program.

• Global expansion is underway, with filings in Japan, China, and Europe, and a prefilled syringe submission to support self-administration.