Firazyr® (Icatibant Acetate Injection) Officially Available to Chinese HAE Patients, Marking a New Era in Hereditary Angioedema Treatment

SHANGHAI, Nov. 1, 2021 /PRNewswire/ -- On Oct. 30, Feizeyou, a therapeutic drug introduced by Takeda China for the treatment of acute attacks of hereditary angioedema (HAE),^®(Icatibant Acetate Injection) has officially become accessible to Chinese patients with hereditary angioedema (HAE). Patients diagnosed by the Department of Allergy at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, have for the first time completed integrated online and offline fulfillment via JD Pharmacy, marking Firazyr's^®(Icatibant Acetate Injection) will safeguard the lives of patients with hereditary angioedema, ushering in a new era of HAE treatment in China.

Takeda remains steadfast in its patient-centric commitment. Since its approval in April this year, the company has accelerated all import formalities and drug quality inspections: the product arrived at a Chinese port on August 31, completed batch testing on October 15, and has recently achieved commercial availability. Feizeyou®^®(Icatibant Acetate Injection) is a portable, ready-to-use prefilled syringe that allows patients to self-administer after receiving training on subcutaneous injection techniques from a healthcare professional.^[1], to help patients promptly manage acute attacks of HAE, avoiding the fatal risk of asphyxiation due to laryngeal edema or alleviating the physical and psychological distress caused by edema in other body parts.

Hereditary angioedema (HAE) is a rare autosomal dominant genetic disorder.^[2]. According to the literature, its global prevalence is approximately 1 in 50,000.^[2]. The primary clinical manifestation of HAE attacks is recurrent localized subcutaneous or mucosal edema, commonly involving the face, extremities, genital region, gastrointestinal tract, and larynx. It is crucial to note that laryngeal edema progresses rapidly, with an average time of 4.6 hours from onset to asphyxiation.^[3]。According to statistics, 58.9% of HAE patients in China have experienced laryngeal edema.^[3], its case fatality rate can reach up to 40%^[2], is one of the leading causes of death in patients with HAE. In 2018, HAE was included in China's *First Catalog of Rare Diseases*.^[4]。

Previously, China lacked targeted therapies for acute HAE attacks. Patients had to rely on infusions of lyophilized fresh plasma to alleviate edema, an approach subject to numerous restrictions. Moreover, plasma inherently contains edema-inducing proteases and their substrates, which may potentially exacerbate angioedema.^[5]。 As of October 2021, Feizeyou^®(Icatibant Acetate Injection) isChina's first and currently the only treatment for acute HAE attacksSelective bradykinin B2 receptor antagonist for subcutaneous administration^[6], with a unique mechanism of highly selective competitive binding to the bradykinin B2 receptor, it alleviates cutaneous, gastrointestinal, and respiratory mucosal edema caused by elevated bradykinin levels in HAE, shortens the duration of edema attacks, and thereby treats acute hereditary angioedema attacks.^[2],[5]. Additionally, the Canadian HAE diagnosis and treatment guidelines recommend^[7], as long-term prophylaxis cannot completely eliminate the risk of edema, all patients should have at least two doses of on-demand medication available, and their ability to self-administer the medication should be regularly assessed.

Prof. Zhi Yuxiang, Department of Allergy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciencesstated: "In the past, due to the lack of targeted therapeutic drugs for acute HAE attacks in China, patients' actual emergency needs could not be met. However, bradykinin B2 receptor antagonists are the on-demand treatments recommended by major international HAE clinical guidelines for acute attacks."^[8],[9]. Now, I am truly pleased that patients' lives are finally safeguarded, sparing them from the physical and psychological distress caused by acute episodes, as well as the associated life-threatening risks, and enabling them to enjoy a better quality of life with renewed confidence and hope.”

To further enhance patient access to innovative rare disease medications, Takeda has partnered with JD Pharmacy. Leveraging its integrated online and offline pharmaceutical fulfillment capabilities, the collaboration provides patients with services including remote issuance of refill prescriptions by specialists, online medication purchasing, and home delivery, thereby improving access to a broader range of rare disease treatments. Cold-chain delivery has currently been launched across 21 provinces, autonomous regions, and municipalities—including Beijing, Hebei, Hubei, Jiangxi, and Guangdong (covering a total of 215 cities)—with additional regions being progressively rolled out. This initiative will safeguard the lives of HAE patients in China.

Statement

1. This article is intended to convey cutting-edge information in the medical and pharmaceutical fields and does not constitute a recommendation or promotion of any drug or diagnostic and therapeutic regimen.

2. For more information on diseases, medicines, or diagnosis and treatment, please consult a healthcare professional.

[1] Feizeyou® Prescribing Information. 2020

[2] National Health Commission, Office of the Expert Committee on Diagnosis, Treatment, and Guarantee of Rare Diseases (Peking Union Medical College Hospital). Guidelines for the Diagnosis and Treatment of Rare Diseases (2019 Edition). 2019.

[3] Xu YY, et al. Ann Allergy Asthma Immunol. 2014, 112(6):539-544.

[4] National Health Commission, Ministry of Science and Technology, Ministry of Industry and Information Technology, National Medical Products Administration, National Administration of Traditional Chinese Medicine. First Batch Catalogue of Rare Diseases, Guo Wei Yi Fa [2018] No. 10.

[5] Yao Xiaojian, Qin Kun, Zhang Tangde. Research Progress on the Prevention and Treatment of Hereditary Angioedema[J]. Journal of Dermatology and Venereology Treatment, 2018, 25(1): 53-56. DOI: 10.3969/j.issn.1674-8468.2018.01.014.

[6] National Health Commission, Office of the Expert Committee on Diagnosis and Treatment of Rare Diseases (Peking Union Medical College Hospital). Guidelines for the Diagnosis and Treatment of Rare Diseases (2019 Edition). 2019.

[7] Betschel S , Badiou J , Binkley K , et al. The International/Canadian Hereditary Angioedema Guideline[J]. Allergy Asthma and Clinical Immunology, 2019, 16.

[8] Busse P J, et al. The Journal of Allergy and Clinical Immunology: In Practice, 2021, 9(1):132-150.

[9] Betschel S, et al. Allergy Asthma and Clinical Immunology, 2019, 15:72.