Halozyme Announces Approval of VYVDURA with ENHANZE® for CIDP Treatment
Tuesday, December 31, 2024
Halozyme Therapeutics has announced that VYVDURA, developed by argenx and featuring Halozyme’s ENHANZE® drug delivery technology, has received regulatory approval in Japan.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a rare autoimmune disorder causing progressive weakness and sensory loss due to nerve damage. Symptoms include muscle weakness, numbness, and difficulty walking.
Diagnosis involves nerve tests and treatment includes immunotherapy like IVIG or steroids. Early intervention is essential to prevent disability and improve patient outcomes.
The Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
The treatment offers a subcutaneous injection option, administered weekly within 30 to 90 seconds, and can be self-administered at home. VYVDURA is the first neonatal Fc receptor (FcRn) blocker to gain approval for CIDP treatment.
The approval is supported by data from the ADHERE study, which is the largest clinical trial conducted to date for CIDP. The study demonstrated that 69% of patients treated with VYVDURA showed clinical improvements in mobility, function, and strength, irrespective of prior treatments.
The trial also achieved its primary endpoint, showing a significant reduction in the risk of relapse compared to placebo. Most participants continued into the ADHERE+ open-label extension study, highlighting the treatment’s favourable safety and efficacy profile.
VYVDURA was previously approved by the MHLW in January 2024 for manufacturing and marketing and was launched in April 2024 for treating generalised myasthenia gravis (gMG).
It was also designated as an Orphan Drug for CIDP treatment in March 2024.
Source: halozyme.com
