Holland-based argenx SE (NASDAQ: ARGX) has announced receiving another indication approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Vygart Hytrulo (efgartigimod alfa subcutaneous injection; SC). This approval allows the drug to be used for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), who can now self-administer the treatment at home. This follows an earlier MHLW approval for the use of Vygart Hytrulo in generalized myasthenia gravis (gMG) in January this year.
ADHERE Study Results Support Vygart Hytrulo’s Efficacy
The endorsement is supported by the results from the ADHERE study, which demonstrated clinical improvement, including improvements in mobility, function, and strength, in 69% (221/322) of patients treated with Vygart Hytrulo. The study successfully met its primary endpoint (p<0.0001), showing a 61% reduction in the risk of relapse versus placebo (HR: 0.39 95% CI: 0.25; 0.61). The safety profile of Vygart Hytrulo is consistent with previous findings, further validating its use in patients with CIDP.
Vygart Hytrulo’s Composition and Delivery Technology
Vygart Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed under the trade name Vygart, and recombinant human hyaluronidase PH20 (rHuPH20), utilizing Halozyme’s Enhanze drug delivery technology to facilitate the subcutaneous injection delivery of biologics.
argenx’s Licensing Deal with Zai Lab Ltd
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) obtained the rights to Vygart Hytrulo through a licensing deal with argenx in 2021, expanding the drug’s reach into the Chinese market and further solidifying argenx’s position as a global player in the biologics space.-Fineline Info & Tech
