Takeda's Icatibant Acetate Injection Nears Approval in China for Acute Hereditary Angioedema Attacks

On March 25, the NMPA website showed that the marketing application (Acceptance No.: JXHS2000083) for Takeda’s “Icatibant Acetate Injection” had its processing status updated to “Under Review,” indicating imminent approval. This drug was previously included in the CDE’s List of Overseas New Drugs in Urgent Clinical Need. According to the prior public notice on priority review, its indication is “for the treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents, and children aged ≥2 years.”

Icatibant, developed by Shire (a subsidiary of Takeda), is a highly selective bradykinin B2 receptor antagonist. It treats acute localized swelling associated with hereditary angioedema by inhibiting the effects of bradykinin, which are responsible for the localized swelling, inflammation, and pain symptoms in hereditary angioedema attacks.

Globally, the drug was first approved for marketing in the European Union on July 11, 2008, and received FDA approval in 2011, becoming the third FDA-approved therapy for hereditary angioedema. In China, Takeda did not submit its marketing application for this drug until June 11, 2020. Currently, according to the Insight database, three additional domestic generic versions have been submitted for marketing approval, originating from Chengdu Shengnuo, Hengrui, and Hansoh.

From: Insight Database (http://db.dxy.cn/v5/)

Hereditary Angioedema (HAE) is a rare autosomal dominant genetic disorder, with the majority of cases (75%) presenting between the ages of 10 and 30. Clinically, patients with HAE experience recurrent acute episodes of soft tissue edema affecting multiple anatomical sites, including the gastrointestinal tract, facial tissues, vocal cords and larynx, oropharynx, urogenital region, and extremities. Laryngeal attacks can be life-threatening due to the risk of asphyxiation, imposing a substantial economic and psychological burden on both patients and their families.

On May 11, 2018, the National Health Commission of China, together with four other departments, jointly formulated the "First Batch of Rare Diseases Catalog," which included hereditary angioedema (HAE). At that time in China, there were no effective therapeutic drugs available for acute HAE attacks, and danazol was the only medication available for prophylaxis. Approximately 28,000 HAE patients in China faced the dilemma of having no effective treatment options.

However, in December 2020, Takeda’s lanadelumab was approved for marketing in China for the prevention of angioedema attacks in patients aged 12 years and older with hereditary angioedema (HAE), marking the first time that HAE patients in China had access to targeted therapy.

Today, Takeda’s marketing application for “Icatibant Acetate Injection” has entered the administrative approval phase, signaling that patients with this condition may soon have access to the first acute treatment drug.