Takeda (NYSE:TAK) has announced that in the open-label Phase 3 SPRING study, children aged 2 to <12 had 94.8% fewer hereditary angioedema (HAE) attacks during treatment with Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline.
The Osaka, Japan–based company plans on presenting the data at the European Academy of Allergy and Clinical
The SPRING study also had positive, clinically meaningful results in children under 6. Children in that age bracket currently have no approved long-term prophylaxis treatment (LTP).
The SPRING study’s findings align with prior studies focused on adults and adolescents.
Takeda aims to submit global regulatory filings later this year.
The primary objective of the SPRING study was to investigate the safety and pharmacokinetics of Takhzyro in patients aged 2 to <12 years with HAE. The prevention of HAE attacks was a secondary outcome measure.
“HAE is a rare condition where unpredictable symptoms like severely debilitating swelling can take a toll on children both physically and emotionally,” said Dr. Marcus Maurer, professor of dermatology and allergy at Charité – Universitätsmedizin Berlin, Germany and principal investigator of the SPRING study. “In the SPRING study, we saw a majority of children who had been suffering nearly two HAE attacks per month on average at baseline, who were then attack-free throughout the 52-week trial of treatment with TAKHZYRO,” Maurer continued in a news release.
Participants in the trial received a dose of 150 mg every four weeks for patients 2 to <6 years and every two weeks in patients aged 6 to <12 years.
Lanadelumab was first developed by Dyax. In 2015, Shire Pharmaceuticals acquired Dyax for $6.5 billion. In 2019, Takeda acquired Shire Pharmaceuticals for approximately $62 billion.