Takeda’s Firazyr® Approved in China for Acute Hereditary Angioedema Attacks, Enhancing Patient Safety

On April 8, Takeda China announced Feizeyou^®(Icatibant Acetate Injection) has been officially approved by the National Medical Products Administration,Indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents, and children aged ≥2 years. Feize You^®(Icatibant Acetate Injection) isChina's First and Currently OnlyA selective competitive antagonist of the bradykinin B2 receptor for subcutaneous treatment of acute hereditary angioedema (HAE) attacks, which allows patients to self-administer after receiving subcutaneous injection training from healthcare professionals. Previously, there were no targeted therapies for acute HAE attacks in China; patients had to rely on infusions of lyophilized fresh plasma to reduce edema, a approach with significant limitations and the risk that plasma-derived bradykinin could exacerbate swelling. Feizeyou^®(The approval of Icatibant Acetate Injection) will fill the gap in targeted treatment for acute HAE attacks in China, safeguarding the lives of Chinese HAE patients.

Bradykinin B2 receptor antagonists are the recommended on-demand treatment regimens for acute attacks in major international HAE diagnosis and treatment guidelines. Feizeyou, approved this time^®(Icatibant Acetate Injection) features a unique mechanism of highly selective antagonism of the bradykinin B2 receptor, which can inhibit skin, gastrointestinal, and respiratory mucosal edema caused by increased bradykinin levels in HAE, thereby treating acute hereditary angioedema attacks. To date, Feizeyou^®(Icatibant Acetate Injection) has been approved in 38 countries/regions and has over a decade of real-world usage experience.

Hereditary angioedema (HAE) is a rare autosomal dominant genetic disorder. According to literature reports, its global prevalence is approximately 1 in 50,000. The hallmark of HAE is recurrent episodes of localized subcutaneous or mucosal edema, commonly affecting the face, extremities, genital area, gastrointestinal tract, and larynx. Most HAE patients experience unpredictable attacks that are frequent and typically moderate to severe in intensity. It is crucial to note that laryngeal edema can progress rapidly; if not treated promptly, it can lead to asphyxiation and death within 4.6 hours. Statistics indicate that 58.9% of HAE patients in China have experienced laryngeal edema, with a mortality rate as high as 40%, making it one of the leading causes of death among HAE patients. In 2018, HAE was included in China’s “First Batch of Rare Diseases Catalog.”

“Due to the current lack of targeted therapeutic agents for acute attacks of hereditary angioedema (HAE) in China, management relies solely on the infusion of lyophilized fresh plasma to resolve edema. However, plasma is not readily accessible, and its use in hospitals is subject to numerous restrictions. Furthermore, plasma itself contains bradykinin, posing a risk of exacerbating edema in patients, thereby failing to meet the actual clinical needs of patients.”Professor Zhi Yuxiang, Department of Allergy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciencesstated: “We are delighted to introduce new innovative therapies to China, enabling patients with hereditary angioedema (HAE) to receive timely treatment during acute attacks, thereby facilitating rapid relief of symptoms, shortening attack duration, and reducing the risk and severity of attacks.”

Multiple Phase III clinical trials and a post-marketing real-world observational study have confirmed that Feizeyou^®(Icatibant Acetate Injection) rapidly targets and alleviates edema in HAE attacks at various sites, with favorable tolerability and safety profiles. Data from the FAST series of Phase III controlled studies show that Feizeyou^®(Icatibant Acetate Injection) for the treatment of acute HAE attacks, nearly 100% of patients achieved relief, with a median time to onset of symptom relief ranging from 2.0 to 2.5 hours, significantly shorter than that in the placebo group (4.6 to 19.8 hours) and the active control group (12.0 hours). Another real-world study, IOS, showed that when self-administered, Firazyr^®(Icatibant acetate injection) also elicited a rapid response, consistent with that observed in controlled studies. In November 2018, Feizeyou^®(Icatibant Acetate Injection) was included in the “First Batch of Overseas New Drugs in Urgent Clinical Need” and, in October 2020, was granted priority review and approval by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, exempting it from domestic clinical trials for registration purposes, thereby accelerating the availability of this international orphan drug to Chinese patients with hereditary angioedema (HAE).

“We sincerely appreciate the priority review and approval by the relevant government authorities, which enabled Takeda to introduce two innovative therapeutic products for Chinese patients with hereditary angioedema (HAE) within just one year. These advancements address the urgent needs for both prophylactic treatment and management of acute attacks, thereby providing comprehensive protection for patients’ health and life safety.”Mr. Shan Guohong, President of Takeda China“As a global biopharmaceutical company deeply rooted in the field of rare diseases in China, Takeda has always adhered to the philosophy of ‘patients first,’ continuously introducing multiple innovative therapies for rare diseases and actively collaborating with all parties to promote the vigorous development of the rare disease sector in China. This effort aims to usher in a new era of hope for patients with rare diseases in China, enabling them to enjoy healthy lives and a brighter future.”