Biopharmaceutical company Halozyme Therapeutics Inc (NASDAQ: HALO) announced on Monday that pharmaceutical company Takeda has received regulatory approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for HYQVIA (Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase), designed for patients with agammaglobulinemia or hypogammaglobulinemia, primary or secondary immunodeficiency disorders that result in dangerously low antibody levels and increased risk of infections.

HYQVIA combines Immunoglobulin 10% with Halozyme's ENHANZE drug delivery technology, which uses recombinant human hyaluronidase (rHuPH20) to enhance the dispersion and absorption of immunoglobulin during subcutaneous injection. This allows for larger volumes to be infused, reducing the frequency of dosing to once every 3 to 4 weeks, compared to weekly or bi-weekly intervals required for conventional subcutaneous immunoglobulin (SCIG) therapies. Notably, this also eliminates the need for venous access.

The approval is based on data from two pivotal Phase 3 studies conducted in Japan (NCT05150340, NCT05513586), which demonstrated the efficacy, safety, and tolerability of HYQVIA in 16 patients aged 2 years or older. Results showed that the immunoglobulin levels remained stable, with a geo-mean IgG trough level of 9.494g/L, comparable to those seen with intravenous or other subcutaneous treatments. Common adverse reactions included pyrexia and infusion site reactions. Data from North American studies were also included in the submission.

Halozyme's ENHANZE technology has been licensed to several major pharmaceutical companies, including Takeda, Roche and Pfizer, and is used to enhance the subcutaneous delivery of various therapeutic drugs.