Shire announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Firazyr (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.
“Until now, HAE patients faced challenges gaining rapid access to acute treatment such as the need to travel to the physician’s office or hospital,” says Timothy Craig, professor of medicine and pediatrics, Penn State Hershey Medical Center. “Firazyr can be carried and stored at room temperature and self-injected by the patient.”
HAE is a debilitating rare genetic disease characterized by recurrent, sometimes disfiguring and often painful episodes of acute swelling which can be life-threatening in some cases. The swelling attacks can affect any part of the body but most commonly occur in the face, gastrointestinal tract, extremities or genitals. Laryngeal attacks can be fatal due to the risk of suffocation.
Firazyr has orphan drug designation status in the EU and US for the treatment of acute HAE. Firazyr is supplied in a pre-filled syringe that can be stored at room temperature (up to 77° Fahrenheit), making it portable and accessible for immediate treatment of HAE attacks. Firazyr’s active substance, icatibant, is a potent and selective bradykinin B2 receptor antagonist. It represents a novel, targeted, subcutaneously administered approach to the treatment of HAE attacks. By inhibiting the effects of bradykinin, which is thought to be responsible for HAE symptoms of localized swelling, inflammation, and pain, Firazyr treats the clinical symptoms of an acute HAE attack.
Release Date: August 25, 2011
Filed Under: Drug Discovery