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Takeda’s Hyqvia 10% SC Injection Receives the Japanese Approval to Treat Agammaglobulinemia or Hypogammaglobulinemia

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Takeda’s Hyqvia 10% SC Injection Receives the Japanese Approval to Treat Agammaglobulinemia or Hypogammaglobulinemia

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  • 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

Related News:- Takeda Presents P-III Trial (ADVANCE-CIDP 1) Results of Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy at PNS 2023, Published in the JPNS

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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