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On March 25, the NMPA official website indicated that the listing application of Takeda's "icatibant acetate injection" (acceptance number: JXHS2000083) was changed to "under approval" and will be approved in the near future.
Icatibant, developed by Shire, a subsidiary of Takeda, is a highly selective bradykinin B2 receptor antagonist that inhibits local swelling, inflammation, and pain symptoms associated with the embolization of hereditary angioedema The effect of bradykinin, thereby treating acute hereditary angioedema embolism local swelling.
Globally, the drug was first approved for marketing in the European Union on July 11, 2008, and was approved for marketing by the FDA in 2011, becoming the third hereditary angioedema treatment drug approved by the FDA.
From: Insight database (http://db.
Hereditary angioedema (HAE) is a rare autosomal dominant genetic disease, most (75%) onset in 10 to 30 years of age.
On May 11, 2018, the National Health Commission and other five departments jointly formulated the "First Batch of Rare Disease Catalog", and hereditary angioedema was included in it.
However, in December 2020, Takeda's Ranarizumab was approved for marketing to prevent the onset of angioedema in HAE patients 12 years of age and older.
Today, Takeda's "Iatibant Acetate Injection" listing application has entered the administrative approval stage, which means that this type of patient may usher in the first acute treatment drug.
