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news.Jerini has announced the submission of its electronic new drug application for Icatibant in the treatment of hereditary angioedema to the FDA as well as the company's request for priority review.
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Jerini has received technical clearance of its electronic common technical document from the agency, which ensures that the documentation meets the agency’s technical standards. Priority review designation, which shortens the regulatory review period from 10 to six months, will also be decided by the agency in this timeframe.
Icatibant, a synthetic peptidomimetic, works by blocking the B2 receptor as an antagonist to the peptide hormone bradykinin that has been shown to be elevated in HAE patients and responsible for edema formation during hereditary angioedema (HAE) attacks.
Jens Schneider-Mergener, CEO of Jerini, said: “The new drug application (NDA) submission is a major milestone for Jerini. This important regulatory step in the US along with Icatibant’s already accepted European filing demonstrates our commitment to bring this novel treatment to HAE patients in both the US and Europe.”