Icatibant
Treatment for AngioedemaFDA Issues Not Approvable Letter for Icatibant
FDA Issues Not Approvable Letter for Icatibant in the Treatment of HAE
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
For questions, please contact: Stacy Wiedenmann Director Investor
Relations & Corporate Communications Jerini AG Invalidenstr.
130 10115 Berlin T + 49 - 30 - 97893 - 285 X + 49 - 30
- 97893 - 105 wiedenmann@jerini.com www.jerini.com
Related Articles:
FDA Cancels Advisory Committee Meeting for Icatibant in the Treatment of HAE - Priority Review of Jerini's NDA Continues - January 8, 2008
Jerini Receives NDA Filing Acceptance and Priority Review from the FDA for Icatibant in the Treatment of HAE - December 21, 2007
Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review - October 31, 2007
Jerini Initiates FDA Submission Process of New Drug Application for Icatibant in the Treatment of HAE - October 8, 2007
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