FDA to Review Application for First Drug to Treat Hereditary Angioedema
The FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet Feb. 20 to discuss Jerini’s new drug application for Firazyr to treat attacks of hereditary angioedema, a genetic disease causing spontaneous and recurring edema attacks in various parts of the body.
If approved, Firazyr (icatibant acetate) would be Jerini’s first product on the market and the first product approved in the U.S. to treat the disease, according to the company.
The company plans to start a Phase II clinical trial of Firazyr to treat drug-induced angioedema in 2008 to expand the drug’s indications.
For more information on the advisory committee meeting, go to www.fda.gov/OHRMS/DOCKETS/98fr/2007-4340-nm00001.pdf.