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Firazyr

Treatment for Angioedema

Update: Firazyr (icatibant) Now FDA Approved - August 25, 2011

FDA Issues Not Approvable Letter for Icatibant

FDA Issues Not Approvable Letter for Icatibant in the Treatment ofHAE

BERLIN, Germany, April 24, 2008 - Jerini AG has received a not approvable letter from the FDA for its New Drug Application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE). The not approvable letter outlines areas of concern that the company is now going to review with the agency. Jerini is expecting an opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for Icatibant in the treatment of HAE later today.

ISIN: DE0006787476 Regulated Market / Prime Standard; Frankfurt Stock Exchange, Germany

Posted: April 2008

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