Takeda's Takhzyro Shows Positive Results In Prevention Of HAE Attacks In Phase 3 Study In Children

(RTTNews) - Takeda's takhzyro or lanadelumab demonstrated positive results in the prevention of hereditary angioedema attacks in phase 3 SPRING study in children ages 2 to less than 12 years.

In this study, hereditary angioedema patients received a dose of 150 milligrams (mg) every 4 weeks in patients 2 to less than 6 years and every 2 weeks in patients aged 6 to less than 12 years.

According to the study results, Takhzyro reduced the rate of Hereditary Angioedema or HAE attacks in children by a mean of 94.8% over the 52-Week treatment period compared to baseline. The majority of patients (76.2%) were attack-free during the 52-week treatment period with an average of 99.5% attack-free days.

No deaths or serious treatment-emergent adverse events (TEAEs) were reported during the study, and no patients withdrew from the study due to TEAEs. The most commonly reported TEAE was injection site pain, and most TEAEs were mild or moderate in severity.

The results are consistent with the favorable efficacy and safety profile of takhzyro observed in earlier studies with adult and adolescent patients.

The global regulatory filings is expected to begin in fiscal year 2022.