Takeda Announces Approval of TAKHZYRO® (lanadelumab) subcutaneous injection in China for the Treatment of Hereditary Angioedema
− TAKHZYRO is the first approved modern therapy for the preventive treatment of hereditary angioedema (
− TAKHZYRO is a subcutaneous injection that took the majority of patients one minute or less to self-administer2
“The approval of TAKHZYRO is exciting news for the HAE community in China,” said
HAE is a rare, genetic disorder estimated to affect about 1 in 50,000 people worldwide.4 The condition results in recurring attacks of oedema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat, that can be debilitating and painful. Laryngeal attacks that obstruct the airways are potentially life-threatening due to the risk of asphyxiation.5,6
“This milestone demonstrates Takeda’s ongoing commitment to support the HAE community globally, as we work to expand access to TAKHZYRO and potentially 14 more highly innovative Takeda medicines to China’s patients over the next five years,” said
In the 26-week Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™, which included 125 people with HAE, TAKHZYRO reduced the mean number of monthly HAE attacks by 87% relative to placebo when administered at 300 mg every two weeks and 73% relative to placebo when administered at 300 mg every four weeks (adjusted P<0.001). A prespecified, exploratory analysis showed that over the entire 26-week study (days 0-182), 44% (n=12/27) of patients taking TAKHZYRO 300 mg every two weeks were attack-free vs. 2% (n=1/41) of patients taking placebo. A post-hoc sensitivity analysis showed that 77% (n=20/26) of the patients receiving TAKHZYRO 300 mg every two weeks were attack-free during a steady-state (day 70-182) vs. 3% of patients on placebo (n=1/37).3 The most commonly reported treatment-emergent adverse events (excluding HAE attacks) in patients treated with TAKHZYRO during the entire treatment period were injection site pain (42.9%), viral upper respiratory tract infection (23.8%), headache (20.2%), injection site erythema (9.5%), injection site bruising (7.1%), and dizziness (6.0%). Most treatment-emergent adverse events (98.5%) were mild to moderate in severity.3 The HELP Study™ is the largest randomised, controlled clinical prevention study conducted to date in HAE.
TAKHZYRO has a half-life of approximately two weeks and may be self-administered as one subcutaneous injection every two weeks, only after training by a healthcare professional.3 The recommended starting dose is 300 mg every two weeks. A dosing interval of 300 mg TAKHZYRO every four weeks is also effective and may be considered if the patient is well-controlled (e.g., attack free) for more than six months. In clinical trials, the majority of patients took within 10 to 60 seconds to administer the injection.2
TAKHZYRO is currently available in more than 20 countries and additional regulatory submissions are ongoing worldwide.
About TAKHZYRO® (lanadelumab)
TAKHZYRO®(lanadelumab) is indicated for prophylaxis to prevent attacks of hereditary angioedema (
TAKHZYRO is formulated for subcutaneous administration and has a half-life of approximately two weeks in patients with HAE. TAKHZYRO is intended for the self-administration or administration by a caregiver, only after training by a healthcare professional.3
TAKHZYRO is not intended for the treatment of acute HAE attacks.
TAKHZYRO Safety Information for China
TAKHZYRO is indicated for prophylaxis to prevent attacks of hereditary angioedema (
TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.
Allergy to any ingredients in TAKHZYRO.
Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, discontinue TAKHZYRO administration and institute appropriate treatment. TAKHZYRO is not indicated for treatment of acute HAE attacks.
The most commonly observed adverse reactions (≥10% and higher than placebo) associated with TAKHZYRO were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea. Less common adverse reactions observed included elevated levels of transaminases; one patient discontinued the trial for elevated transaminases.2,3
Use in Specific Populations: The safety and efficacy of TAKHZYRO in pediatric patients <12 years of age have not been established.2
No data are available on TAKHZYRO in pregnant women. No data are available on the presence of lanadelumab in human milk or its effects on breastfed infants or milk production.2
For more information, visit https://www.takeda.com.
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in
1 TAKHZYRO China Prescribing Information. 2020.
2 TAKHZYRO (lanadelumab-flyo) [prescribing information].
3 Banerji A, Riedl MA, Bernstein JA, et al; for the HELP Investigators. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121.
4 Cicardi M, Bork K, Caballero T, et al, on behalf of HAWK (
5 Longhurst HJ,
6 Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.