Angioedema

Icatibant gets orphan drug designation

Published in Blood Weekly, December 18th, 2003

Jerini announced that effective December 2003, the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Jerini's BK2 receptor antagonist Icatibant (JE049) for the treatment of angioedema.

This follows the announcement by Jerini in January that the European Agency for the Evaluation of Medicinal Products had granted orphan drug designation to Icatibant for the same indication. Jerini will file an investigational new drug application (IND) for Icatibant in this indication with the U.S. FDA. Regulatory approvals for the IND are expected for March 2004. Jerini is currently conducting an open phase II...

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Source: Blood Weekly (2003-12-18)

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