- SHP643-301 is A Multicenter, Open-Label Phase 3 Study to Evaluate Safety, PK, Pharmacodynamics, And Clinical Activity/Outcomes of TAKHZYRO for Prevention Against Acute Attacks of HAE in Pediatric Patients 2 To <12 Years of Age
- Safety Profile Was Consistent With That Seen in the Clinical Program for Patients 12 Years and Older; There Were No Serious Adverse Events
- Global Regulatory Filing for Children Ages 2 to <12 Years of Age Planned to Begin this Fiscal Year
Takeda (TSE:4502/NYSE:TAK) today announced that the Phase 3 SHP643-301 study (NCT04070326) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. The safety profile was consistent with that seen in the clinical program for patients 12 years of age and older; there were no serious adverse events and no dropouts due to adverse events.1
The study also successfully reached the secondary objective evaluating the clinical activity/outcome of TAKHZYRO in preventing hereditary angioedema (HAE) attacks as well as characterizing the pharmacodynamics of TAKHZYRO in pediatric subjects 2 to <12 years of age.
“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, Takeda. “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.”
“I’m pleased that TAKHZYRO has met these key objectives and I look forward to Takeda sharing further insights with the HAE community in the near future,” said Dr. Marcus Maurer, Professor of Dermatology and Allergy Charité – Universitätsmedizin Berlin, Germany and principal investigator of SHP643-301.
SHP643-301, also known as the SPRING study, is a multicenter, open-label Phase 3 study to evaluate the safety, PK and PD of TAKHZYRO for prevention against acute attacks of HAE in pediatric patients 2 to <12 years of age. Participants aged 2 to < 6 years received lanadelumab at a dose of 150 milligrams (mg) every 4 weeks (q4wks) over 52-week treatment period. Participants aged 6 to <12 years received lanadelumab at a dose of 150 mg every 2 weeks (q2wks) over 52-week treatment period. This study is complete, and full results will be presented at upcoming medical meeting(s).1
We look forward to discussing these data with global health authorities.
About TAKHZYRO ® (lanadelumab-flyo) Injection
TAKHZYRO is a completely mortal monoclonal antibody that specifically binds and decreases tube kallikrein and is indicated for routine forestallment of intermittent attacks of HAE in cases progressed 12 times and aged. It was studied in one of the largest forestallment studies in HAE with the longest active treatment duration, and TAKHZYRO constantly demonstrated HAE attack reduction. TAKHZYRO is formulated for subcutaneous administration and has a half- life of roughly two weeks. TAKHZYRO is intended for tone- administration or administration by a caregiver formerly trained by a healthcare professional.2
TAKHZYRO Safety Information for Europe
Please consult the TAKHZYRO Summary Product Characteristics (SmPC) before defining.
TAKHZYRO treatment should be initiated under the supervision of a croaker endured in the operation of cases with heritable angioedema (HAE). TAKHZYRO may be tone- administered or administered by a caregiver only after training on SC injection fashion by a healthcare professional.3
Acuity to the active substance or to any of the excipients.3
About Hereditary Angioedema
Hereditary angioedema (HAE) is a rare inheritable complaint that results in recreating attacks of oedema – lump – in colorful corridor of the body, including the tummy, face, bases, genitals, hands and throat. The lump can be enervating and painful Attacks that obstruct the airways can beget asphyxiation and are potentially life hanging HAE affects an estimated 1 in people worldwide. It’s frequently under honored, under diagnosed and under treated.
Takeda in Hereditary Angioedema
Hereditary Angioedema (HAE), like so numerous other rare conditions, is largely complex, and cases, their families and caregivers frequently suffer times of strain trying to understand their complaint, get a definitive opinion and gain access to the drugs they need. At Takeda we’re a married champion for the cases we serve. Every individual living with HAE is unique and by harkening and replying to their requirements, we restate the perceptivity we gain into innovative results – from opinion to ongoing operation. Advancing the wisdom is pivotal to the way we operate and we’re bold in our charge to accelerate opinion and develop treatments that will make a difference to the lives of HAE cases, their support networks and those medical professionals who watch for them.
Takeda is a global, values- grounded, R&D- driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life- transubstantiating treatments, guided by our commitment to cases, our people and the earth. Takeda focuses its R&D sweats on four remedial areas Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Tube- Deduced Curatives and Vaccines. We’re fastening on developing largely innovative drugs that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and using our enhanced cooperative R&D machine and capabilities to produce a robust, modality-different channel. Our workers are committed to perfecting quality of life for cases and to working with our mates in health care in roughly 80 countries and regions.