#Japan #Halozyme #Tokyo #VYDURA #CIDP

Regulatory Approval for VYDURA in Japan

On December 30, 2024, Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced a significant development in the realm of biopharmaceuticals with Japan's Ministry of Health, Labour and Welfare (MHLW) granting regulatory approval for VYDURA (efgartigimod alfa and hyaluronidase-qvfc). This drug, co-formulated with Halozyme's advanced ENHANZE® drug delivery technology, is specifically designed for adults suffering from Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

An Innovative Treatment Approach

VYDURA represents a noteworthy advancement as it is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP treatment. The drug can be administered via a self-injected subcutaneous method, which takes between 30 to 90 seconds once a week—offering patients the convenience of at-home treatment.

Dr. Helen Torley, president and CEO of Halozyme, expressed satisfaction at the approval, highlighting the significance of VYDURA as a treatment option for both CIDP and generalized myasthenia gravis (gMG). She noted, "We are pleased that VYVDURA, with our innovative ENHANZE drug delivery technology, is now approved for two indications in Japan, enabling greater flexibility and optionality for CIDP patients."

Data Supporting the Approval

The approval was predicated on results from the ADHERE Study, the largest clinical trial conducted for CIDP to date. In this pivotal study, a remarkable 69% of participants (221 out of 322) who received VYDURA exhibited clinical improvements, including enhancements in mobility, functionality, and strength. The trial's success was highlighted by a significant reduction in the risk of relapse, with results meeting the primary endpoint (p<0.0001)—showing a 61% decrease in relapse risk when compared to placebo treatments.

Notably, an overwhelming 99% of participants opted to continue into the ADHERE+ open-label extension, underscoring the drug's efficacy and acceptance among trial subjects. Safety data revealed results consistent with previously established safety profiles for VYDURA in earlier clinical trials and real-world applications.

Broader Implications for CIDP Treatment

Beyond this recent approval in Japan for CIDP, VYDURA won its first approval for commercial manufacturing and marketing for gMG in January 2024, followed by its launch in April. The MHLW also designated VYDURA as an Orphan Drug for CIDP treatment in March 2024, further emphasizing its importance in addressing underserved medical needs.

Halozyme Therapeutics continues to make strides in enhancing patient experiences through innovation. The company is known for its proprietary enzyme rHuPH20 within the ENHANZE® platform, which has already positively impacted over 800,000 patients worldwide. By licensing this technology to various leading pharmaceutical firms, including Roche, Takeda, and AbbVie, Halozyme aims to transform the way therapies are delivered, ensuring not only efficacy but also enhancing the convenience of treatment.

About Halozyme Therapeutics

Headquartered in San Diego, California, Halozyme develops and commercializes novel drug delivery systems and associated products. The company's two flagship commercial products, Hylenex® and XYOSTED®, further exhibit its commitment to enhancing health outcomes through innovative solutions. With ongoing partnerships and development projects in the pipeline, Halozyme remains committed to advancing therapeutic options for challenging conditions like CIDP.

For more information about VYDURA, ENHANZE®, and Halozyme Therapeutics' ongoing work, please visit Halozyme's official website. Connect with them on social media platforms like LinkedIn and Twitter for the latest updates and innovations in the biopharmaceutical industry.