Takeda's HYQVIA Approved in Japan for Agammaglobulinemia and Hypogammaglobulinemia
核心洞察
Japan's MHLW has approved Takeda (搜索)'s HYQVIA for treating agammaglobulinemia (搜索) and hypogammaglobulinemia (搜索), conditions marked by low antibody levels.
HYQVIA is the first facilitated subcutaneous immunoglobulin therapy available in Japan, offering less frequent dosing.
The approval is based on Phase III trials in Japanese and North American patients, demonstrating efficacy and manageable side effects.
Takeda (搜索) Pharmaceutical's HYQVIA (Immune Globulin Infusion 10% (搜索) with Recombinant Human Hyaluronidase) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of agammaglobulinemia (搜索) and hypogammaglobulinemia (搜索). These disorders are characterized by significantly reduced or absent antibody levels, predisposing individuals to heightened risks of recurring and severe infections stemming from primary or secondary immunodeficiency (搜索).
The approval marks HYQVIA as the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy accessible to patients in Japan. This offers a novel treatment avenue for individuals affected by these conditions. HYQVIA is also being evaluated for additional indications in Japan.
The approval was based on data derived from two pivotal Phase III trials. These trials assessed the efficacy, safety, tolerability, and pharmacokinetics of HYQVIA in Japanese patients diagnosed with primary immunodeficiency (搜索) (PID). The submission to the MHLW also incorporated data from two Phase III clinical trials conducted in North American patients with PID.
Naoyoshi Hirota, regional head of Research & Development for Takeda (搜索)’s Plasma-Derived Therapies Business Unit in Japan, stated, "We are delighted that HYQVIA, approved in more than 40 countries worldwide, has now been approved in Japan. The subcutaneous IG therapies currently available in Japan for patients with agammaglobulinemia (搜索) or hypogammaglobulinemia (搜索) 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 is formulated as a combination of Immune Globulin Infusion 10% (搜索) and recombinant human hyaluronidase PH20 (rHuPH20). The rHuPH20 component enhances the dispersion and absorption of the immunoglobulin within the subcutaneous tissue. This facilitation allows for the infusion of larger volumes at the injection site, consequently enabling less frequent dosing compared to conventional subcutaneous immunoglobulin products. Furthermore, this administration route circumvents the necessity for venous access during therapy delivery. The ability to infuse a larger volume is expected to increase administration flexibility for patients with agammaglobulinemia (搜索) or hypogammaglobulinemia (搜索) 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.
Kristina Allikmets, head of R&D for Takeda (搜索)’s Plasma-Derived Therapies Business Unit, noted the high unmet need for plasma-derived therapies (PDTs) in Japan, which is anticipated to grow with improved education and diagnosis rates. "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 (搜索)’s March 2023 announcement of a ¥100 billion (approximately US$635 million) investment in a new manufacturing facility for plasma-derived therapies (PDTs) in Osaka, Japan.