Takeda’s Takhzyro (lanadelumab-flyo) Receives the US FDA’s sBLA Approval to Prevent Hereditary Angioedema Attacks in Children Aged ≥2 Years
Shots:
- The US FDA has approved the sBLA for the expanded use of Takhzyro for prophylaxis to prevent attacks of HAE in pediatric patients aged 2-<12yrs.
- The approval was based on the P-III trial (HELP Study) evaluating Takhzyro as well as PK & PD data from the P-III trial (SPRING Study). The (SPRING Study) showed a mean 94.8% reduction in HAE attacks with mean monthly attacks from 1.84 to 0.08 per patient @52wks., attack-free (76.2%) with 99.5% attack-free days, no deaths or serious TEAEs were reported & no patients withdrew from the study due to TEAEs
- The recommended dose of 150mg/1 mL solution from the single-dose prefilled syringe therapy, administered q4w in children aged 2-<6yrs. and q2w in aged 6-<12yrs. The results were consistent with the favorable efficacy & safety profile of Takhyzro
Ref: Takeda | Image: Takeda
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