EC approves Jerini's Firazyr

The EC approved Firazyr icatibant from Jerini (Xetra:JI4) to treat acute attacks of hereditary angioedema (HAE). Jerini said it is the first drug to be approved in all EU countries for the indication. The company plans to launch the selective peptidomimetic bradykinin B2 receptor antagonist this quarter. Earlier this month, Shire (LSE:SHP; NASDAQ:SHPGY) proposed to acquire Jerini (See BioCentury, July 07, 2008).

Firazyr has Orphan Drug status in the EU and Orphan Drug designation in the U.S., where the drug received a not approvable letter in April. A complete response is expected to be submitted to FDA within the next three to four months. Jerini has rights to Firazyr from sanofi-aventis (Euronext:SAN; NYSE:SNY). ...