Takeda Reveals Positive Data on Takhzyro at EAACI
Takeda today revealed positive data from its Phase 3 Spring study on Takhzyro (lalnadelumab) for preventing hereditary angioedema (HAE) attacks in patients aged between 2 and 12.
Besides causing rapid and recurrent swelling of body parts that could be dangerous or fatal, HAE also exerts a mental burden on patients, with many experiencing anxiety, difficulties with social activities and barriers to career advancement.
There are no approved long-term prophylactic treatments for HAE in patients younger than 6. Takhzyro’s latest results could be the tipping point for its approval in younger age groups.
The data was presented at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2022.
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Results From the Phase 3 Spring Study
HAE is characterized by recurrent, rapid and severe swelling of body parts such as the limbs and abdomen. Fluids constantly accumulate outside of the blood vessels, blocking the flow of blood and lymphatic fluid. Swelling can also block the airway and is potentially fatal.
Takhzyro is a fully human monoclonal antibody that binds plasma kallikrein, an enzyme involved in the release of bradykinin. As bradykinin is a peptide that promotes inflammation and swelling, slowing its release helps prevent HAE attacks.
In Takeda’s presentation, children treated with Takhzyro experienced 94.8% fewer HAE attacks over the 52-week treatment period compared to baseline. 76.2% of patients were attack-free during this period with an average of 99.5% attack-free days.
No deaths or serious adverse events related to the treatment emerged during the study. The most common side effects included injection site pain. Most treatment-emergent adverse events were mild or moderate, and did not lead to discontinuation of treatment. The results were consistent with the efficacy and safety profile of Takhzyro in earlier studies with adult and adolescent patients.
“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,” said Dr. Marcus Maurer, Professor of Dermatology and Allergy Charité – Universitätsmedizin Berlin, Germany and principal investigator of the SPRING study.
In the multicenter, open-label Phase 3 Spring study, participants aged 2 to <6 received a subcutaneous injection of Takhzyro at a dose of 150 mg every 4 weeks for 52 weeks. Those aged 6 to <12 received the same dose every 2 weeks for 52 weeks, with the option to reduce dose frequency to every 4 weeks if they do not suffer HAE attacks for 26 weeks.
Approved in the US, EU, China, and Japan
Takhzyro was first granted approval in the US in 2018 for the preventive treatment of HAE in patients aged 12 and older. An approval in Europe soon followed the same year.
In 2020, Takeda announced the NMPA approval of Takhzyro for the prevention of HAE. More recently this March, Takhzyro was approved in Japan under the same indication.
Takhzyro was originally developed by Shire before its $62.2 billion acquisition by Takeda in 2018.
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