Firazyr icatibant regulatory update

FDA's Pulmonary-Allergy Drugs Advisory Committee voted 12-1 that the efficacy and safety data for Firazyr icatibant from Shire support approval to treat acute attacks of hereditary angioedema (HAE) in adults. The panel also voted 11-1 with 1 abstention that the data support self-administration of subcutaneous injections of Firazyr, which is supplied in a prefilled syringe that can be stored at room temperature. The 2 drugs approved in the U.S. to treat acute HAE attacks - IV Berinert from CSL Ltd. (ASX:CSL, Melbourne, Australia) and subcutaneous Kalbitor ecallantide from Dyax Corp. (NASDAQ:DYAX, Cambridge, Mass.) - must be administered by a healthcare professional.

The committee also voted 12-1 that the selective peptidomimetic bradykinin B2 receptor ( BDKRB2; B2R) antagonist showed a clinically meaningful benefit and 11-1 with 1 abstention that it showed adequate safety. While the agency had expressed concerns about whether the company's novel Visual Analog Scale (VAS) was appropriate for evaluating the primary endpoint of time to onset of symptom relief, data on additional efficacy endpoints convinced the panelists that VAS was a valid measure. ...