Jerini icatibant meeting with FDA expected in April

Berlin, Germany-based Jerini AG has received notification from the US Food and Drug Administration of its decision to cancel the Pulmonary-Allergy Drugs Advisory Committee meeting scheduled for February 20.

The meeting was originally planned to provide a forum for FDA advisors to discuss the data included in Jerini's New Drug Application for icatibant in the treatment of hereditary angioedema, a disease for which there is currently no approved treatment in the USA. The agency has told the company that an advisory committee meeting is no longer necessary, and that it will continue its priority review of the NDA.

"The results of our Phase III studies demonstrate icatibant's safety and efficacy in treating HAE. We look forward to the FDA's decision and to our receipt of the agency's action letter, which is expected on April 26, 2008," said Jens Schneider-Mergener, chief executive of Jerini.