Dublin, Ireland and Lexington, Massachusetts, US - March 3, 2011- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the European Commission has approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. FIRAZYR is the first and only treatment for acute Type I and Type II hereditary angioedema (HAE) attacks licensed for self-administration in Europe.
"Given the unpredictable and potentially life-threatening nature of attacks, a self-administered treatment for HAE can provide reassurance to patients that effective medication is close at hand to treat the attack," said Philip J. Vickers, Senior Vice President of Research and Development, Shire HGT. "We have been committed to ensuring that self-administration with FIRAZYR is an option for those suffering from HAE in Europe, and are delighted to have received European Commission approval."
The Phase IIIb Evaluation of the Safety of Self-Administration with Icatibant (EASSI) study data supported the label change. The study was designed to evaluate safety, local tolerability, convenience and efficacy of self-administered FIRAZYR for the symptomatic treatment of acute HAE attacks in FIRAZYR naïve and non-naïve HAE patients.
Based on an analysis of initial data from this ongoing study, time from injection to symptom relief for self-administered FIRAZYR was consistent with healthcare professional-administered FIRAZYR therapy in the previously published FAST-1 and FAST-2 studies.
The European Commission approval of the FIRAZYR label change to include self-administration is valid in all of the 27 EU Member States plus Iceland, Liechtenstein and Norway.
FIRAZYR is currently approved in 37 countries worldwide, including the countries of the European Union. On February 28, 2011, Shire announced the submission of a complete response to the not approvable letter issued by the US Food and Drug Administration regarding its New Drug Application for FIRAZYR.
The active substance, icatibant, is a specific bradykinin B2 receptor antagonist. It represents a novel, targeted, subcutaneously-administered approach to the treatment of HAE attacks designed to block the effects of bradykinin, the key mediator of edema formation. FIRAZYR is a synthetic decapeptide (a peptide containing ten amino acids).
For patients who have never previously received FIRAZYR, the first treatment should be given in a medical institution or under the guidance of a physician. In cases of insufficient relief or recurrence of symptoms after treatment with FIRAZYR, patients should seek medical advice, and subsequent doses should be given in a medical institution. The decision to initiate self-administration should only be taken by a physician experienced in the diagnosis and treatment of HAE.
Patients with laryngeal attacks should always seek medical advice and be managed in an appropriate medical institution after self-administration of FIRAZYR, until the physician considers discharge to be safe.
Icatibant has an orphan drug designation status in the EU and US for treatment of hereditary angioedema. Where commercially available, the drug is supplied in a pre-filled 3 ml syringe. FIRAZYR can be stored at up to 25 degrees Celsius without refrigeration.
FIRAZYR is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information.
Last updated on: 03/03/2011