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FDA Approves Shire's FIRAZYR® (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)
Date:8/25/2011

tance, 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."

Free Trial and Co-Pay Assistance for Eligible U.S. Patients

With today's FDA approval of FIRAZYR, Shire has initiated a Quick Start program and extended its OnePath Access Program to offer a wide range of product-related services and support to HAE patients.

Following prescription from their health care provider, all patients enrolling in the Quick Start program may be eligible to receive two syringes of FIRAZYR at no cost. Enrollment in OnePath offers a co-pay assistance program for eligible patients. A patient assistance program is available for certain patients who are currently uninsured or have insurance that does not cover treatment. In addition, at the physician's request, OnePath offers patients in-person self-administration training by a healthcare professional. For more information on Shire's OnePath services please visit http://www.onepath.com or call 1(866) 888-0660.

About FIRAZYR

FIRAZYR is currently approved in 38 countries worldwide, including the countries of the European Union and the United States for the treatment of acute attacks of HAE in adults.

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SOURCE Shire plc
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