Argenx presents data from ADHERE trial evaluating Vyvgart Hytrulo

Argenx announced that data from its Phase 3 ADHERE trial evaluating Vyvgart Hytrulo in patients with chronic inflammatory demyelinating polyneuropathy, or CIDP, were presented for the first time to the medical community during the Clinical Trials Plenary Session at the American Academy of Neurology, or AAN, annual meeting in Denver, Colorado. Argenx also highlighted clinical trial and real-world data across seven posters and presentations that continue to reinforce Vyvgart and Vyvgart Hytrulo as a transformative treatment option for gMG patients. In the ADHERE study, a majority of patients treated with Vyvgart Hytrulo, regardless of prior treatment, demonstrated evidence of rapid clinical improvement, and a reduced risk of relapse compared to those treated with placebo. As previously reported, ADHERE met its primary endpoint demonstrating a 61% reduction in the risk of relapse versus placebo. Vyvgart Hytrulo was well-tolerated, and the observed safety and tolerability profile was consistent with previous clinical trials. Evidence of rapid onset and maintenance of clinical response: In the open-label Stage A of the ADHERE study, 67% of patients treated with Vyvgart Hytrulo demonstrated evidence of clinical improvement, or ECI, including 40% who had achieved ECI by the earliest possible measure at week 4. In Stage B, Vyvgart Hytrulo-treated patients maintained a clinical response to treatment longer than those on placebo as evidenced by a statistically significant and clinically relevant reduction in risk of relapse. Results across both Stage A and B indicate IgG autoantibodies play a significant role in mediating the underlying biology of CIDP. Overall, 81% of Vyvgart Hytrulo-treated patients demonstrated one point improvement on the aINCAT as compared to baseline Stage A scores in ADHERE, which includes 42% of patients with two-point improvement, 28% with three-point improvement, and 12% with four-point improvement. Clinical benefit was seen across all patient subtypes, including those who had previously received corticosteroids, intravenous or subcutaneous immunoglobulin, or were on no treatment prior to study entry. In total, 99% of eligible patients continued to the ADHERE-Plus open-label extension study. Data from the ADHERE trial were submitted to the FDA as part of a supplemental Biologics License Application, or sBLA, for VYVGART Hytrulo for the treatment of CIDP. The application was accepted for priority review in February and has been granted a PDUFA target action date of June 21.