Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today 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," said Timothy Craig, Professor of Medicine & Pediatrics, Penn State Hershey Medical Center. "FIRAZYR is a treatment with demonstrated efficacy that can be carried and stored at room temperature and self-injected by the patient. FIRAZYR addresses this important unmet need by providing HAE patients with fast access to acute treatment."

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.

"The unpredictability of HAE attacks can place limits on patients' travel, employment opportunities, educational opportunities, and social life," said U.S. HAE Association Executive Vice President Janet Long. "With this approval, patients have an important new option to treat HAE attacks."

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.

"Shire has extensive experience meeting the unique needs of patients with rare diseases due to our leadership in this area," said Sylvie Grégoire, President of Shire HGT. "With FIRAZYR now approved in 38 countries, we are pleased to bring both this novel treatment and our comprehensive OnePath^® patient service and support program to U.S. HAE patients."

SOURCE Shire plc