News of the approval was widely expected after an expert panel voted to endorse the treatment back in June.
"Having a product like Firazyr that is portable, that you can carry with you, can be stored at room temperature and that you can self-administer at the onset of an attack is a huge advancement for these patients," Sylvie Grégoire, president of Shire HGT, told FierceBiotech.
HAE is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function, says the FDA. It can cause swelling all over the body, and its attack on airways can be deadly. Fewer than 30,000 people in the United States have HAE.
Firazyr was given the green light in Europe three years ago, and now with US FDA approval Shire expects sales of the product to grow rapidly in the years to come.
Shire is the Title Sponsor of the World Orphan Drug Congress USA, and Sylvie Gregoire spoke at the inaugural event in Washington, D.C. earlier this year. For more information on the 2012 conference, stay tuned!