Takeda’s Hyqvia 10% SC Injection Receives the Japanese Approval to Treat Agammaglobulinemia or Hypogammaglobulinemia
Shots:
- The Japanese MHLW has approved Hyqvia 10% SC injection for agammaglobulinemia & hypogammaglobulinemia, linked to primary or secondary immunodeficiency. Additional indications are under review
- Approval was supported by 2 pivotal P-III studies (NCT05150340, NCT05513586) in Japanese PID patients (n=16; ≥2yrs.), showing Geo Mean of IgG trough level of 9.494g/L comparable to IV/SC immunoglobulin treatments (Geo Mean 9.624 g/L). Data from North American trials (NCT00814320, NCT01175213) also supported the submission
- Hyqvia consists one vials of Immunoglobulin 10% and Recombinant Human Hyaluronidase PH20 (rHuPH20) each. This enables larger volumes to be infused, reducing dosing frequency to Q3W-Q4W
Ref: Takeda | Image: Takeda
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