FDA gives Jerini angioedema drug priority review
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)










