FDA gives Jerini angioedema drug priority review

Fri Dec 21, 2007 3:59am EST
 
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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.

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)

 
Dr. Qurrath U. Ain of the Elmhurst Pediatric Emergency Center examines a patient with flu-like symptoms at Elmhurst Hospital in New York in this December 12, 2003. file photo. REUTERS/Shannon Stapleton/Files
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