The plasma kallikrein inhibitor Takhzyro (lanadelumab) from Takeda (TSE:4502/NYSE:TAK) met its objectives in a Phase 3 study focused on hereditary angioedema (HAE) in children aged 2 to 12 in an open-label Phase 3 study.
In the SHP643-301 multicenter, open-label study, Takhzyro also had a safety profile similar to that observed in clinical trials focused on patients 12 years old and older.
HAE involves recurring episodes of severe (angioedema) in various body parts, including the abdomen, limbs, face, intestinal tract, genitals, hands and throat.
HAE attacks involving the airways can be potentially life-threatening.
Takhzyro recently won approval in Japan as a prophylaxis against acute attacks of HAE.
“We are encouraged by these results, as each objective met instills further confidence in the potential to bring a treatment option to this vulnerable population,” said Ashley Yegin, global medical unit head, HAE, global medical affairs at Takeda, in a statement. “With more than a decade of experience and innovation in HAE, Takeda is committed to continued support for patients of all ages with this devastating condition.”
Takhzyro won FDA approval for hereditary angioedema in 2018.