Takeda Receives Japanese Regulatory Approval for HYQVIA Subcutaneous Injection for Treating Agammaglobulinemia or Hypogammaglobulinemia

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Editor's note: this story was originally published on BioPharmInternational.com.

The Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Takeda's HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] to treat patients with agammaglobulinemia or hypogammaglobulinemia, Takeda announced on Dec. 27, 2024. Agammaglobulinemia and hypogammaglobulinemia are disorders characterized by very low or absent levels of antibodies. Patients suffering from these disorders have an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID) (1,2). This approval makes HYQVIA the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy to be made available as a treatment option for patients in Japan, according to a company press release. HYQVIA is also under review in Japan for additional indications.

The approval is based on data from two pivotal Phase III trials that evaluated the efficacy, safety, tolerability, and pharmacokinetics in Japanese patients with PID. Data from two Phase III clinical trials in patients with PID in North America were also included in the MHLW submission.

“We are delighted that HYQVIA, approved in more than 40 countries worldwide, has now been 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 (1). “The subcutaneous IG therapies currently available in Japan for patients with agammaglobulinemia or hypogammaglobulinemia require infusion once every week or every two weeks. We are proud to offer Japanese patients the first and only facilitated subcutaneous treatment option that offers a reduced dosing frequency of every three or four weeks.”

HYQVIA comprises a combination of one vial of IG 10% and one vial of recombinant human hyaluronidase PH20 (rHuPH20); rHuPH20 increases the dispersion and absorption of IG in the subcutaneous tissue. This increased dispersion and absorption allows for larger volumes to be infused at the infusion site, which in turn allows for less frequent dosing compared to other subcutaneous IG products. Meanwhile, this route of administration can avoid the need to access veins for delivering the therapy. Takeda noted in its press release that the ability to infuse a larger infusion volume is expected to increase administration flexibility for patients with agammaglobulinemia or hypogammaglobulinemia by decreasing the dosing frequency to once every three or four weeks, compared to the weekly or bi-weekly dosing schedule with conventional SCIG treatments.

“There is a high unmet need for plasma-derived therapies (PDTs) in patients in Japan, which is anticipated to increase as education and timely diagnosis rates continue to 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, is further evidence of Takeda’s commitment to add to the standard of care for patients in Japan. We look forward to continuing to bring new therapeutic options that support and enhance the experience of patients in our home country throughout the next decade.”

The approval follows Takeda’s previous announcement in March 2023 that the company is investing ¥‎100 billion (US$754 million at the time of the announcement; current conversion is US$635 million) into building a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan (3).

References

1. Takeda. Takeda Announces Approval of HYQVIA 10% S.C. (Subcutaneous) Injection Set in Japan for Patients with Agammaglobulinemia or Hypogammaglobulinemia. Press Release. Dec. 27, 2024.
2. Pimenta, F. M. C. A.; Palma, S. M. U.; Constantino-Silva, R.N.; Grumach, A.S. Hypogammaglobulinemia: A Diagnosis that Must Not Be Overlooked. Braz. J. Med. Biol. Res. 2019, 52 (10), e8926. DOI: 10.1590/1414-431X20198926
3. Takeda. Takeda to Invest 100 Billion JPY in a New Manufacturing Facility for Plasma-Derived Therapies in Japan. Press Release. March 23, 2023.