BERLIN, Dec. 21, 2007 (PRIME NEWSWIRE) -- On December 20, 2007, Jerini AG (FSE:JI4) received filing acceptance of its New Drug Application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE) from the U.S. Food and Drug Administration (FDA). Jerini was also granted priority review by the agency, which is intended for those products that address unmet medical needs and provides for a review period of six months from the date of submission. Jerini submitted the NDA on October 26, 2007. Under the Prescription Drug User Fee Act (PDUFA), the FDA has issued an action date of April 26, 2008, which is the agency's deadline for making a decision on the application. In addition, the FDA has scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting on February 20, 2008, to discuss Icatibant. Advisory committees provide advice to the agency and are often held as part of the review process for a drug that is the first in a new class of therapeutics.
ISIN: DE0006787476
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