Takeda Reports the US FDA’s Acceptance of sBLA for Takhzyro (lanadelumab-flyo) to Prevent Hereditary Angioedema Attacks in Children Aged ≥2 Years
Shots:
- The US FDA has accepted an sBLA of Takhzyro for prophylaxis to prevent HAE attacks in pediatric patients aged 2 to <12yrs. The sBLA was based on the P-III (SPRING) study of Takhzyro (150mg, q4w) in patients aged 2 to <12yrs. with HAE for 52wk.
- The results showed a ~95% reduction in HAE attack rate over baseline, 76.2% were attack-free with 99.5% attack-free days, TEAEs (81.0%), no deaths, serious TEAEs, hospitalizations, or discontinuations due to TEAEs were seen, the extent of reduction was similar b/w patients with 150mg lanadelumab q4w or q2w
- If Takhzyro is approved, it will be 1st treatment for patients aged ≤6yrs. & is available in 30+ countries globally. The US FDA has granted priority review of the application with an expected decision in H1’23
Ref: Businesswire | Image: Takeda
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