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− TAKHZYRO for adult and paediatric patients aged 12 years and older1
− Approval of the effects of the global Phase 3 HELP Study™, Phase 3 HELP OLE, and a Phase 3 examination in Japanese patients comparing the efficacy and protection of TAKHZYRO1
− In a rapid phase 3 study in Japan, 41. 7% of patients did not increase seizures in the efficacy assessment period (26 weeks) after subcutaneous treatment of this drug once every two weeks1
OSAKA, Japan and CAMBRIDGE, Mass. , March 28, 2022–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) announced that it has obtained approval from the Department of Health, Labor and Social Services (MHLW) for three-hundred-mg TAKHZYRO® (lanadelumab) subcutaneous injection syringes for acute attack prophylaxis of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older in Japan. 1
Hereditary angioedema (HAE) is a rare genetic disorder that causes recurrent attacks of edema (swelling) in parts of the body, including the abdomen, face, feet, genitals, hands, and throat. Swelling can be debilitating and painful. 2,3, 4 Attacks that clog airlines can cause choking and be potentially fatal. 2,5. HAE affects about 1 in 50,000 people worldwide. 2 In Japan, it is estimated that between 2,000 and 3,000 people live with HAE, but only about 450 have been diagnosed due to low awareness of the disorder in the country. 3
This approval is based primarily on the effects of the global Phase 3 Help study (long-term prophylaxis of hereditary angioedema) and the Phase 3 Help Open-label Extension (OLE) study, in addition to the effects of a Phase 3 study comparing the efficacy and protection of TAKHZYRO in Japanese patients. Together, these studies have demonstrated the efficacy and protection profile of TAKHZYRO as a preventive remedy for HAE attacks. 1,6,7
“In addition to the burden of debilitating and life-threatening HAE attacks, the unpredictable nature of this disease presents significant demanding situations for patients and their support networks,” said Naoyoshi Hirota, director general of the Takeda Development Center, Japan. “We hope that TAKHZYRO, a new treatment option for patients in Japan living with HAE, as well as the efficacy and protection profile as a preventive remedy presented in global studies and in a rapid Phase 3 study in Japan, will contribute to the treatment of HAE.
TAKHZYRO obtained its first approval for the prevention of HAE attacks in patients over the age of 12 in 2018 in the United States and the European Union, and is now approved in more than 50 countries. a caregiver once trained through a healthcare professional. 4 TAKHZYRO is supported by a clinical progression program, which includes one of the largest HAE prevention studies with the longest duration of active treatment7 with the most ongoing regulatory filings worldwide.
About HELP6,7 in the randomized, double-blind, placebo-controlled HELP study, which included 125 HAE patients, lanadelumab reduced the average number of monthly HAE attacks by 87% compared to placebo when 300 mg each and every two weeks was administered and 73% compared to placebo when 300 mg is given every four weeks (adjusted P
Hereditary angioedema (HAE), like so many other rare diseases, is very complex, and patients, their families, and caregivers spend years of strain seeking to perceive their disease, obtain a definitive diagnosis, and have access to the medications they need. At Takeda, we are a champion committed to the patients we serve. Each user living with HAE is unique and by listening and reacting to their needs, we translate the wisdom we gain into cutting-edge responses, from diagnosis to immediate management. Advancing science is very important to the way we function and we are ambitious in our project to drive diagnosis and expand remedies that will make a difference in the lives of HAE patients, their support networks and the healthcare professionals who care for them.
TAKHZYRO® (lanadelumab) injection
TAKHZYRO is a fully human monoclonal antibody that in particular binds to and decreases plasma kallikrein and is indicated for the prophylaxis regimen against acute haE attacks in patients over 12 years of age. It has been studied in one of the largest and longest-running HAE prevention studies. of active treatment, and TAKHZYRO has consistently demonstrated relief in HAE attacks. TAKHZYRO is formulated for subcutaneous administration and has a half-life of approximately two weeks. 4
Product Name
Three hundred mg TAKHZYRO subcutaneous injection syringes
Generic
Lanadélumab (genetic recombination)
Indications and effects
Prophylaxis of acute attacks of hereditary angioedema (HAE)
Dosage and administration
The dose for adult and paediatric patients over 12 years of age is three hundred mg of lanadelumab (genetic recombination) injected subcutaneously every two weeks. Lanadelumab can be injected subcutaneously every four weeks.
About TakedaTakeda is a global biopharmaceutical leader, value-based and driven by R
TAKHZYRO Safety information for Europe
Refer to the takhzyro Summary of Product Characteristics (SmPC) prescription.
Treatment with TAKHZYRO should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). TAKHZYRO can be self-administered or administered through a caregiver only after receiving education in the subcutaneous injection (SC) strategy through a healthcare professional.
ContraindicationHypersensitivity to the substance or to any of the excipients. 4
Warnings and precautions Traceability: For the traceability of biological medicinal products, the mark and batch number of the administered product must obviously be registered. 4
Hypersensitivity reactions have been observed. In the event of a severe hypersensitivity reaction, takhzyro deserves to be discontinued without delay and the appropriate remedy initiated. 4
General: TAKHZYRO is not designed for the treatment of acute HAE attacks. In the event of an outbreak of HAE, individualized treatment with an approved rescue drug should be initiated. There is no clinical knowledge about the use of lanadelumab in HAE patients with general C1-INH activity. 4
Interference with the coagulation test: Lanadelumab would possibly increase the activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT test. The reagents used in the aPTT laboratory test initiate intrinsic coagulation by activating plasma kallikrein in the tactile system. Inhibition of plasma kallikrein through lanadelumab would possibly increase aPTT in this test. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. groups. 4
Sodium content: This medicine contains less than 1 mmol of sodium (23 mg) consistent with the vial, which is necessarily “sodium-free”. 4
Interactions No drug interaction studies have been conducted. Given the characteristics of lanadelumab, pharmacokinetic interactions with co-administered medicinal products are not expected.
Unsurprisingly, concomitant use of the C1 esterase inhibitor has additive effects on the lanadelumab-cHMWK reaction depending on the mechanism of action (MOA) of lanadelumab and the C1 esterase inhibitor. 4
Immunogenicity Treatment with lanadelumab was associated with the progression of anti-drug antibodies (ADA) that appeared under treatment in 11. 9% (10/84) of the subjects. All antibody titers were low. Response to ADA was brief in 20% (2/10) of ADA-positive subjects. 2. 4% (2/84) of subjects treated with lanadelumab tested positive for neutralizing antibodies. 4
Progression of ADA comprising neutralizing antibodies against TAKHZYRO did not appear to adversely affect pharmacokinetic (PK) and pharmacodynamic (PD) profiles or clinical response. 4
Adverse reactions The maximum non-unusual adverse reaction (52. 4%) was related to injection site reactions (IHR) of TAKHZYRO, adding pain at the injection site, erythema at the injection site, and bruising at the injection site. Intensity, 90% resolved within the first day of onset with a median duration of 6 minutes. 4
A hypersensitivity reaction (mild to moderate pruritus, discomfort and tingling of the tongue) (1. 2%) was observed4
Very unusual (frequency ≥1/10):
Injection reactions*
Common (≥1/100 a
Hypersensitivity**, dizziness, maculopapular rash, myalgia, increased alanine aminotransferase, increased aspartate aminotransferase.
*Injection reactions include: pain, erythema, bruising, discomfort, hematoma, hemorrhage, pruritus, swelling, induration, paresthesia, reaction, heat, edema, and rash. 4
** Hypersensitivity includes: pruritus, discomfort and tingling of the tongue. 4
For the summary of the product characteristics of the European Union, visit https://www. ema. europa. eu/en/documents/product-information/takhzyro-epar-product-information_en. pdf.
To obtain all U. S. prescribing information. In the U. S. , adding approved indication and vital protection information, visit https://www. shirecontent. com/PI/PDFs/TAKHZYRO_USA_ENG. pdf
Consult your regulatory company about approved labeling in your country.
Disclaimer The drug data contained in this document is intended to disclose data about the company. Nothing contained herein should be construed as a solicitation, promotion, or indication of any prescription drug other than those in development lately.
references
Packing commands for TAKHZYRO syringes for subcutaneous injection of three hundred mg.
Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations and treatment. Br J Hosp Med. 2006;67(12):654-657.
Hide M, Horiuchi T, et al. Management of hereditary angioedema in Japan: focus on icatibant for the remedy of acute attacks. Allergol Int. 2021 Jan;70(1):45-5.
TAKHZYRO® (lanadelumab) European summary of product characteristics.
Banerji A. La burden in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013; 111 (5): 329-336.
Banerji A, Riedl MA, Bernstein JA, et al. Effect of lanadelumab versus placebo in preventing attacks of hereditary angioedema: a randomized clinical trial. JAMA. 2018;320(20):2108-2121. doi:1001/jama. 2018. 16773
Banerji A, Bernstein JA, Johnston DT, et al. Long-term prevention of hereditary angioedema with lanadelumab: the HELP OLE study. Allergy. 2022;77(3)979-990. doi:10. 1111/all. 15011
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Media Contacts: Japanese Media Ryoko Matsumotoryoko. matsumoto@takeda. com 81 (0) 3-3278-3414U. S. Media Erin-Marie Bealserin-marie. beals@takeda. com 1-781-336-9417Measures outside Japan and the United States Linda Calandralinda. calandra1@takeda. com 1-617-301-2092