Following last week's positive FDA panel vote, Shire plc's Firazyr icatibant is poised to become the first product approved in the U.S. for self administration to treat acute attacks of hereditary angioedema in adults. Uptake could be rapid, as physicians at FDA's Pulmonary-Allergy Drugs Advisory Committee touted the compound's potential to treat acute HAE attacks more quickly and with fewer side effects than current drugs.
The company's robust dataset persuaded the panel that a novel measure of primary endpoints in Phase III trials of Firazyr was meaningful: the committee voted 12-1 in favor of approval, and 11-1 with one abstention that the data support self administration.
HAE is an autosomal-dominant condition in which individuals have either low levels of complement 1 (C1) esterase inhibitor or mutated C1 that is non-functional.
Symptoms include dramatic swelling at various sites, including the face, airways and gastrointestinal tract. The attacks can occur spontaneously and typically last for one to four