jetcityimage/iStock Editorial via Getty Images
- Takeda (NYSE:TAK) said a phase 3 study of Takhzyro for preventing hereditary angioedema (HAE) attacks in children ages two years to <12 years, met its goals.
- Takhzyro is approved for preventing recurrent attacks of HAE in patients aged 12 years and older.
- HAE is a rare disorder characterized by recurrent episodes (attacks) of severe swelling of the skin and mucous membranes.
- The phase 3 trial, dubbed SHP643-301 evaluated the safety and pharmacokinetics (PK) of Takhzyro (lanadelumab) in patients two to less than 12 years of age.
- The Japanese drugmaker said the safety profile was consistent with that seen in the clinical program for patients 12 years of age and older and there were no serious adverse events and no dropouts due to adverse events.
- The company added that study also successfully reached the secondary goal evaluating the clinical activity/outcome of Takhzyro in preventing HAE attacks as well as characterizing the pharmacodynamics of the drug in children between two years to 12 years of age.
- Takeda noted that global regulatory filing for Takhzyro for children ages two to <12 years of age is planned to begin this fiscal year.