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FDA gives Jerini angioedema drug priority review

NEW YORK
Fri Dec 21, 2007 3:59am EST

NEW YORK (Reuters) - German biotech firm Jerini AG said on Friday that U.S. regulators at the Food and Drug Administration have granted priority review of its Icatibant drug for the treatment of skin-swelling disease hereditary angioedema.

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Under the priority review process, which is given to products that address unmet medical needs, the agency has until April 26, 2008 to make a decision on its new drug application (NDA), the company said.

The FDA has scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting on February 28, 2008 to discuss the drug, the company said.

(Reporting by Emily Chasan)



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