Jerini AG begins US NDA submission process for icatibant

Berlin, Germany-based Jerini AG says that its New Drug Application for icatibant in the treatment of hereditary angioedema has been sent to the US Food and Drug Administration via an Electronic Common Technical Document for testing. After receiving technical clearance of the eCTD from the FDA, the regulatory review period will begin, the firm noted. The agent, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin, which has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks.