Takeda’s Hyqvia Receives the US FDA’s sBLA Approval for the Treatment of Childrens with Primary Immunodeficiency
Shots:
- The US FDA has approved an sBLA to expand the use of Hyqvia in children aged 2-16yrs. with PI. The approval was based on evidence from a P-III trial evaluating Hyqvia in 44 patients aged 2 & 16yrs.
- The results showed no clinical differences in trough IgG levels. The therapy was found to be effective with respect to the occurrence of aSBIs @12mos. period, mean aSBI rate/yr. was 0.04 lower than the predefined success rate of less than one aSBI per subject/year
- The efficacy was consistent with a pivotal clinical study, the mean rate of all inf. per subject year was 3.20. Hyqvia was approved in the US for adults & children aged ≥2yrs. with PI & in the EU as replacement therapy in adults, children & adolescents with PI & secondary immunodeficiency
Ref: Takeda | Image: Takeda
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