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Takeda’s Takhzyro (lanadelumab-flyo) Receives the US FDA’s sBLA Approval to Prevent Hereditary Angioedema Attacks in Children Aged ≥2 Years

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Takeda’s Takhzyro (lanadelumab-flyo) Receives the US FDA’s sBLA Approval to Prevent Hereditary Angioedema Attacks in Children Aged ≥2 Years

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  • 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

Related News:- Takeda Reports the US FDA’s Acceptance of sBLA for Takhzyro (lanadelumab-flyo) to Prevent Hereditary Angioedema Attacks in Children Aged ≥2 Years

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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