Jerini AG Receives European Medicines Evaluation Agency Filing Acceptance of Its Marketing Application for Icatibant in the Treatment of Hereditary Angioedema

BERLIN, Aug. 16, 2007 (PRIME NEWSWIRE) -- Jerini AG (FSE:JI4) announced today the acceptance of its Marketing Authorization Application (MAA) by the European Medicines Evaluation Agency (EMEA) on August 15, 2007 for Icatibant in the treatment of hereditary angioedema (HAE). The agency's Committee for Medicinal Products for Human Use (CHMP) has also granted Jerini accelerated assessment for the review of this submission, which shortens the regulatory review period from 210 to 150 calendar days and is granted to drug candidates addressing major public health interest and therapeutic innovation. The start of Jerini's EMEA regulatory review period begins on August 15, 2007, and an opinion from the agency's committee could be received as early as first quarter 2008. EMEA approval provides marketing authorization in all 27 EU member states as well as Norway, Iceland, and Liechtenstein.
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