argenx announces FDA acceptance of sBLA for Vyvgart Hytrulo for CIDP treatment
Betsy Goodfellow | February 20, 2024 | News story | Medical Communications | CIDP, FDA, Neurology, Vyvgart Hytrulo, argenx, sBLA
argenx has announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for priority review.
The drug is intended for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The application has been given a PDUFA target action date of 21 June 2024.
The sBLA is supported by results from the ADHERE study, which assessed the safety and efficacy of subcutaneously administered Vyvgart Hytrulo in adults with CIDP. The study met its primary endpoint, showing a 61% lower risk of relapse when treated with the drug, compared to placebo.
Luc Truyen, chief medical officer of argenx, commented: “Today’s announcement brings us one step closer to delivering the transformative innovation of Vyvgart Hytrulo to CIDP patients. CIDP is yet another example of an autoimmune disease that has not been well understood and for which there has been insufficient innovation for patients. We chose to use a priority review voucher to accelerate 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.”
Betsy Goodfellow
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