The Japanese MHLW Approves Takeda's HYQVIA Subcutaneous Injection

HYQVIA is the first and only facilitated subcutaneous immunoglobulin licensed in Japan to treat Agammaglobulinemia or Hypogammaglobulinemia

On December 27, 2024, Takeda shared that the Japanese Ministry of Health, Labour and Welfare (MHLW) has given the green light to HYQVIA [ Human Immune Globulin Infusion 10% Human with Recombinant Human Hyaluronidase]. This treatment is intended for patients dealing with agammaglobulinemia or hypogammaglobulinemia, conditions marked by significantly low or nonexistent antibody levels. Patients with these disorders have a higher chance of experiencing serious recurring infections due to primary immunodeficiency (PID) or secondary immunodeficiency (SID) (1,2). According to a company press release, the MHLW has approved HYQVIA, making it the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy available as a treatment option for patients in Japan. HYQVIA is currently being evaluated in Japan for more uses.

The approval comes from findings in two important Phase III trials that looked at how well the treatment works, its safety, how well patients can handle it, and how it moves through the body in Japanese patients with PID. The MHLW submission also included data from two Phase III clinical trials involving patients with PID in North America.

“We are very happy that HYQVIA, which has been approved in over 40 countries around the world, is now also approved in Japan,” said Naoyoshi Hirota, regional head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit in Japan, in the press release. “In Japan, patients with agammaglobulinemia or hypogammaglobulinemia can receive subcutaneous IG therapies that need to be infused once a week or every two weeks.” We are excited to provide Japanese patients with a unique treatment option that allows for a simpler dosing schedule of every three or four weeks.

HYQVIA includes one vial of IG 10% and one vial of recombinant human hyaluronidase PH20 (rHuPH20). The rHuPH20 helps to spread and absorb IG in the subcutaneous tissue more effectively. This improved spreading and absorption means that more fluid can be given at the injection site, leading to fewer doses needed compared to other subcutaneous IG products. This way of giving the treatment can skip the need to reach veins for delivering the therapy. Takeda mentioned in its press release that being able to infuse a larger volume is likely to provide more options for patients with agammaglobulinemia or hypogammaglobulinemia. This change could reduce the number of doses needed, allowing for treatment every three or four weeks instead of the usual weekly or bi-weekly schedule with traditional SCIG treatments.

“In Japan, many patients still need plasma-derived therapies (PDTs), and this need is expected to grow as education and diagnosis improve,” said Kristina Allikmets, head of R&D for Takeda’s Plasma-Derived Therapies Business Unit, in the release. “The approval of HYQVIA, the first and only facilitated SCIG treatment, shows Takeda’s dedication to enhancing the standard of care for patients in Japan.” We are excited to keep providing new treatment choices that help and improve the experience of patients in our home country over the next ten years.

Souirce: Takeda