FDA approves Halozyme’s VYVGART Hytrulo for CIDP treatment

Halozyme Therapeutics, Inc. (NASDAQ: HALO) has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) approval of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), co-formulated with ENHANZE, Halozyme’s proprietary recombinant human hyaluronidase enzyme (rHuPH20). This approval marks a new era for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), introducing the first novel mechanism of action in 30 years.

VYVGART Hytrulo is approved as a once weekly 30-to-90 second subcutaneous injection, significantly reducing the treatment burden for CIDP patients. This user-friendly administration is a leap forward in making treatment more accessible and manageable for patients.*

The FDA’s decision is grounded in the results from the ADHERE study, the largest clinical trial to date for CIDP. The study highlighted that 69% (221/322) of patients treated with VYVGART Hytrulo showed clinical improvement, including enhanced mobility, function, and strength. The trial met its primary endpoint with a 61% reduction in the risk of relapse compared to placebo, demonstrating significant efficacy in preventing disease progression.

Safety results from the ADHERE study were consistent with the known safety profile of VYVGART in other clinical settings and real-world use, affirming its reliability and effectiveness for CIDP patients. An impressive 99% of trial participants opted to continue with the treatment in the ADHERE open-label extension, underscoring patient confidence in the therapy.

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, broadening its impact across multiple neurological disorders.

Dr. Helen Torley, President and CEO of Halozyme, expressed enthusiasm about the approval, stating, “With this approval, CIDP patients in the U.S. will have access to the first novel mechanism of action to treat CIDP in 30 years, which lessens the burden of treatment as a 30 to 90 second weekly SC injection.” She emphasized the role of Halozyme’s ENHANZE technology in enhancing patient care through more efficient and effective treatment options.