Takeda's Icatibant Injection Nominated for Priority Review in China for Hereditary Angioedema Acute Attacks

On October 23, the latest public notice from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration indicated that Takeda’s marketing application for icatibant acetate injection is proposed to be included in the priority review program. Icatibant was developed by Shire, a subsidiary of Takeda, and is primarily indicated for the treatment of acute attacks of hereditary angioedema (HAE). Publicly available information shows that it is the third drug approved by the U.S. FDA for the treatment of HAE attacks and had previously been included in China’s list of overseas new drugs urgently needed for clinical use.

▲ Screenshot source: CDE official website

According to public information, icatibant is a potent and 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.

In the United States, icatibant (brand name: Firazyr) was approved by the FDA in 2011 for the treatment of acute attacks of hereditary angioedema in adults aged 18 years and older, making it the third drug approved by the FDA for the treatment of hereditary angioedema attacks.

Information on the CDE website indicates that Takeda submitted its first marketing application for Icatibant Acetate Injection in China this June, which was accepted. Previously, Hansoh Pharmaceutical had submitted a clinical trial application for its generic version of Icatibant Acetate under Category 3.1, and Sinobio had filed a marketing application for its generic version of Icatibant under Category 3.

It is worth noting that icatibant has not yet been approved for marketing in China. The original icatibant product from Takeda is proposed to be included in the priority review, which is expected to accelerate the availability of innovative therapies for patients with hereditary angioedema. According to the CDE website, the indication for this application of icatibant is for the treatment of acute attacks of hereditary angioedema in adults, adolescents, and children aged ≥2 years.

Hereditary Angioedema is a rare genetic disorder characterized primarily by recurrent swelling of the skin, respiratory tract, and visceral organs. When edema affects the airways, it can lead to laryngeal edema; if not treated promptly, this may result in asphyxiation and death. Gastrointestinal involvement often mimics acute abdomen, frequently leading to misdiagnosis as appendicitis or acute pancreatitis and unnecessary emergency exploratory laparotomy. This condition not only poses a life-threatening risk but also imposes a significant economic and psychological burden on patients and their families.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved June 11, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=3

[2]FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE). Retrieved August 25, 2011, from https://www.drugs.com/newdrugs/fda-approves-shire-s-firazyr-icatibant-acute-attacks-hereditary-angioedema-hae-2824.html

Source: Medical Insight

▽Follow [WuXi AppTecTakeda】WeChat Official Account