Shots:

• The P-III (SHP643-301/ SPRING) study evaluates the safety, PK & PD of Takhzyro (50mg, q4w for 52wk.) in pediatric patients aged 2 to <12yrs. with HAE. The patients were aged 6 to <12yrs. received lanadelumab at a dose of 150mg, q2w for 52wk.
• The trial has met its objectives & the safety profile was consistent with that seen in the clinical program for patients aged ≥12yrs. with no serious AEs & no dropouts due to AEs. The study also met the 2EPs of clinical activity/outcome & characterizing the PD of Takhzyro
• The company also plans to initiate the regulatory filing for children aged 2 to <12yrs. in 2022. Takhzyro is a human mAb that binds & decreases plasma kallikrein for HAE

Ref: Businesswire | Image: Takeda