New data from the Phase 3 HELP Study™ Open Label Expansion to evaluate the safety and efficacy of TAKHZYRO® (lanadelumab) in patients with hereditary angioedema will be announced at the European Society of Allergy and Clinical Immunology (EAACI) Hybrid Conference – QNT Press Release


The use of TAKHYZRO for up to 2.5 years of safety and effectiveness analysis is consistent with the initial treatment period, based on more and more evidence of long-term safety and effectiveness

The final patient subgroup analysis showed that the use of TAKHZYRO can reduce HAE episodes within the range of patient demographics and disease characteristics

Takeda Pharmaceutical Co., Ltd. (("http://www.w3.org/1999/xhtml" Relative ="Not following" href="https://cts.businesswire.com/ct/CT?id=smartlink&, url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&, esheet=52457112&, newsitemid=20210710005018&, lan=en-US&, Anchor=TSE%3A4502%2FNYSE%3ATAK&, index=2&, NYSE:and so) (“Takeda”) today announced the results of two final analyses of the third phase of the HELP (long-term prevention of hereditary angioedema) study Open Label Extension (OLE) to evaluate the long-term safety (primary endpoint) and effectiveness of TAKHZYRO® (lanadelumab) 300 mg every two weeks for a maximum of 2.5 years. In the first analysis, compared with the baseline observed in the study population (N = 212), the average (minimum, maximum) reduction in incidence was 87.4% (-100; 852.8), and the median reduction was 97.7% , The patients received treatment with an average (standard deviation) duration of 29.6 (8.2) months.1 In a steady state—on the 70th day after the end of the treatment period—the attack rate further decreased to an average of 92.4%, and the median decreased by 98.2%.2,3 Another analysis further showed that TAKHZYRO is a well-tolerated treatment that can prevent HAE attacks during the 132-week treatment period of the extended program for specific HAE patient demographic and disease characteristics subgroups.3 These data will be announced at the European Society of Allergy and Clinical Immunology (EAACI) mixed conferences in Krakow, Poland and Madrid, Spain in 2021.

“Inherited angioedema is a life-long disease. Studies have shown that fear of recurrence limits the patient’s lifestyle,” said Markus Magerl, MD, Department of Dermatology, Venereology and Allergy at Charité-Universitätsmedizin, Berlin, Germany. “TAKHZYRO’s long-term effectiveness in preventing HAE attacks will become an important consideration for patients and doctors because they have developed a treatment plan for patients that focuses on reducing the number of HAE attacks.”

The initial phase 3 HELP study was conducted in 125 patients 12 years and older for 26 weeks, making it the largest randomized controlled prevention study of HAE to date, with the longest active treatment duration.4 The HELP study OLE aims to evaluate the long-term safety (primary endpoint) and effectiveness of TAKHZYRO for up to 2.5 years. The full results are based on data collected from May 2016 to October 2019, including 109 rollover patients initially evaluated in the HELP study, and 103 eligible non-rollover patients who did not participate in the initial study but who had experienced at least one HAE in the past Onset within 12 weeks.1

Seizure-free status in patients with hereditary angioedema during steady-state treatment with lanadelumab: results from the HELP open-label extension study (e-poster presentation: abstract #342)

The results of the HELP study, OLE, found that TAKHZYRO was continuously effective in preventing the onset of HAE by reducing the attack rate during a treatment period of up to 132 weeks. The half-life of TAKHZYRO is approximately 14 days and is expected to reach a steady state at approximately 70 days. The HELP study’s OLE analysis of seizure-free state during steady state showed that the efficacy of subcutaneous injection of TAKHZYRO 300 mg every two weeks in rollover patients is consistent with the original results of the HELP study.2

Compared with the baseline observed in the study population (N = 212), the average (minimum, maximum) reduction in incidence was 87.4% (-100; 852.8), and the median reduction was 97.7% (98.0% rollover, 96.9) % Non-rollover).1,2 In a steady state, the attack rate is further reduced to an average of 92.4% (-100, 0.44), including 92.7% flip (-100, -40.9) and 91.9% non-flip (-100, 0.44), and a median drop of 98.2 % (98.4% renewal, 97.3% non-renewal). During the first six months of treatment after the 70th day of the steady-state phase, 58.6% of patients (n=119) had no seizures, 54.7% had reversals and 62.9% had no reversals. The longest duration of seizure-free period after ≥6 months on the 70th day is 83.7%, and 70% for ≥12 months. The average and the longest duration of the seizure-free period during the steady-state period were 14.8 and 18.6 months, respectively, and 70.0% of patients (n=142) had the longest seizure-free duration greater than 12 months.2

Use of lanadelumab for long-term prevention of seizures in a subgroup of patients with hereditary angioedema (HAE): final results of the HELP open-label extension study (oral report: abstract #392)

In the further HELP study OLE analysis, the treatment of 300 mg TAKHZYRO every two weeks was well tolerated and prolonged in different patient demographics and disease characteristics (including patient age, gender, race, HAE type, body) During the treatment period, it effectively reduced the seizure rate quality index, long-term preventive use history and baseline seizure rate.3

The safety of TAKHZYRO was comparable in all subgroups evaluated, 54.7% of patients (n=116) had treatment-related TEAEs, the most common being pain at the injection site.3

“For more than ten years, we have listened to the HAE community to further understand the need for long-term preventive targeted therapy, and have invested our resources to develop treatment options,” said Neil Inhaber, MD, vice president of global medical care. Takeda HAE and transplant supervisor. “These analyses further prove the important role that TAKHZYRO can play in the lives of people with HAE.”

About helping researchOpen label extension

HELP (Long Term Prevention of Hereditary Angioedema) Study Open Label Extension (OLE) is an assessment of the long-term efficacy and safety of TAKHZYRO in patients with hereditary angioedema (HAE)…

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