Takeda Submits Icatibant Acetate Injection for Marketing Approval in China to Treat Hereditary Angioedema

By Baihuawen

On June 11, Takeda submitted a marketing application in China for icatibant acetate injection, indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults.

Hereditary Angioedema (HAE) is a rare genetic disorder affecting approximately 1 in 10,000 to 50,000 individuals worldwide. The condition typically presents as recurrent edema in various parts of the body, including the abdomen, face, feet, genitals, hands, and throat. When edema occurs in the larynx, it may obstruct the airway and lead to asphyxiation.

Icatibant is a selective bradykinin B2 receptor antagonist developed by Shire, which treats acute attacks of hereditary angioedema (HAE) by inhibiting the effects of bradykinin associated with HAE symptoms. The drug was approved in the European Union in July 2008 and received FDA approval for marketing in August 2011. In 2017, Shire’s icatibant sales amounted to USD 663 million.

The PharmaGo database from Yiyao Mofang shows that the domestic manufacturers currently developing generic versions of icatibant include Hansoh Pharmaceutical and Shengnuo Biopharmaceutical. Notably, Hansoh Pharmaceutical’s icatibant injection was approved by the FDA for market launch in March 2020.