The US Food and Drug Administration (FDA) has accepted for priority review Argenx‘s sBLA for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) to treat chronic inflammatory demyelinating polyneuropathy (CIDP).
A decision on the approval from the regulator under the Prescription Drug User Fee Act is anticipated by 21 June 2024.
The sBLA submission is based on findings from the ADHERE study, currently the largest clinical trial conducted for CIDP.
It assessed the efficacy and safety of subcutaneous doses of VYVGART Hytrulo in adults.
The trial met its primary endpoint.
VYVGART Hytrulo treatment offered a 61% reduction in relapse risk compared with placebo.
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In Stage A of the open-label trial, 67% of participants exhibited evidence of clinical improvement.
The significance of immunoglobulin G autoantibodies in CIDP’s pathology was underscored by the trial’s findings, given VYVGART Hytrulo’s mechanism as an FcRn [neonatal crystallisable fragment receptor] blocker.
The safety profile of the therapy was consistent with previous clinical trials and its established profile, and it was found to be well-tolerated.
Following the completion of the ADHERE study, 99% of eligible patients opted to continue treatment in the ADHERE-+ open-label extension study.
Luc Truyen, argenx chief medical officer, stated: “The announcement brings us one step closer to delivering the transformative innovation of VYVGART Hytrulo to CIDP patients.
“We chose to use a priority review voucher to accelerate the review of our submission because CIDP patients have long been waiting for new treatment options.
“FDA’s acceptance of the sBLA represents an important milestone in our continued drive to bring novel treatments for rare autoimmune diseases and a significant step forward for people whose lives have been profoundly impacted by this devastating disease.”
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