argenx Receives FDA Approval for VYVGART® Hytrulo with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy
Today, Halozyme announced that the U.S. Food and Drug Administration (FDA) has approved argenx’s VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) co-formulated with ENHANZE® for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). This approval marks a significant advancement as the first novel treatment mechanism for CIDP in 30 years, offering patients a weekly subcutaneous injection lasting between 30 to 90 seconds.
Dr. Helen Torley, President and CEO of Halozyme, expressed enthusiasm about the approval, highlighting how the ENHANZE® technology reduces treatment burden while providing meaningful benefits to patients and healthcare providers. This milestone follows positive outcomes from the ADHERE study, where a majority of patients treated with VYVGART® Hytrulo showed clinical improvement, meeting the study’s primary endpoint by demonstrating a 61% reduction in the risk of relapse compared to placebo.
In addition to CIDP, VYVGART® Hytrulo is also approved in the U.S. for treating generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody positive.
For more information about Halozyme and its innovative drug delivery solutions, visit www.halozyme.com.
Please note: This press release includes forward-looking statements. Actual results may differ materially from those anticipated due to various factors, as detailed in Halozyme’s filings with the Securities and Exchange Commission. The Company undertakes no obligation to update forward-looking statements following the date of this release, except as required by law.
