Takeda Gains Japan Approval for HYQVIA® 10% with ENHANZE® for Immunodeficiencies

SAN DIEGO, Dec. 30, 2024 -- Halozyme Therapeutics, Inc. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval to Takeda for HYQVIA® [Immune Globulin Infusion 10% (Human) combined with Halozyme's Recombinant Human Hyaluronidase]. This approval is significant for patients suffering from agammaglobulinemia or hypogammaglobulinemia, which are conditions where individuals exhibit extremely low or non-existent antibody levels, often leading to severe recurrent infections due to primary or secondary immunodeficiency.

HYQVIA® stands out as the inaugural plasma-based therapy in Japan designed for subcutaneous administration. It consists of a pairing of Immunoglobulin 10% and Recombinant Human Hyaluronidase PH20 (rHuPH20), leveraging Halozyme's ENHANZE® drug delivery technology. This technology facilitates the broader spread and uptake of immunoglobulin within the subcutaneous layer, allowing for larger volume infusions at the site. Consequently, patients benefit from reduced dosing frequencies compared to traditional subcutaneous immunoglobulin therapies, eliminating the need for venous access. This advancement is anticipated to offer greater convenience for patients, enabling them to reduce the frequency of their doses to once every three or four weeks, unlike the weekly or bi-weekly requirements of conventional treatments.

Dr. Helen Torley, president and CEO of Halozyme, expressed satisfaction with the approval, highlighting the enhanced treatment flexibility HYQVIA offers to Japanese patients with agammaglobulinemia or hypogammaglobulinemia. She emphasized the company's commitment to providing innovative drug delivery solutions that enhance the treatment experience.

The MHLW's decision is supported by data from two key Phase 3, open-label, non-controlled trials that assessed the efficacy, safety, tolerability, and pharmacokinetics of HYQVIA® in Japanese patients with primary immunodeficiency. These trials involved 16 participants aged two years and above. Results from these studies demonstrated that the Geo Mean of IgG trough levels at the last three visits was 9.494 g/L, consistent with intravenous or subcutaneous immunoglobulin treatments, which showed a Geo Mean of 9.624 g/L. Notable adverse reactions included fever in five patients (31.3%) and reactions at the infusion site, such as erythema, swelling, pain, and headaches, affecting 12.5% of participants. Additionally, data from two Phase 3 trials conducted in North America were also considered in the approval process.

Halozyme is a biopharmaceutical firm focused on developing innovative solutions to enhance patient experiences and outcomes through existing and novel therapies. Known for its ENHANZE® drug delivery technology, featuring the proprietary enzyme rHuPH20, Halozyme aims to improve the patient experience by facilitating faster subcutaneous delivery of drugs and reducing treatment burdens. With its technology having benefited over 800,000 patients across more than 100 global markets, Halozyme partners with prominent pharmaceutical and biotech companies like Roche, Takeda, Pfizer, and others.

Beyond ENHANZE®, Halozyme also engages in the development, manufacturing, and commercialization of drug-device combination products, often in collaboration with partners. These products aim to offer commercial or practical benefits such as increased convenience, reliability, and patient comfort. The company's proprietary products include Hylenex® and XYOSTED®, and it continues to explore product development opportunities with partners like Teva Pharmaceuticals and Idorsia Pharmaceuticals.

Headquartered in San Diego, California, Halozyme also maintains offices in Ewing, New Jersey, and Minnetonka, Minnesota, with the latter housing its operational facilities.