28th Feb 2011 12:00
Shire Files Complete Response to FDA's Not Approvable Letter for FIRAZYR® (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema
Dublin, Ireland and Lexington, Massachusetts, US- February 28, 2011 - Shire plc , the global specialty biopharmaceutical company,today announced that it has submitted a complete response to the not approvableletter issued by the US Food and Drug Administration (FDA) to Jerini AG inApril 2008 regarding its New Drug Application for FIRAZYR® (icatibant) for thetreatment of acute attacks of hereditary angioedema (HAE). Once the FDAacknowledges receipt of the file, a timeline for completing the review of thisClass II resubmission will be communicated to Shire.Shire's complete response includes additional data requested by the agencyregarding FIRAZYR's efficacy and safety in treating HAE attacks. Shireconducted an additional Phase III clinical study (FAST-3), and in December 2010reported positive efficacy and safety results [http://www.shire.com/shireplc/en/media/shirenews?id=431]. The Company's complete response is based primarily on recent results from the FAST-3study and the ongoing self-administration study,as well as the previously publishedFAST-1 and FAST-2 studies."It is very rewarding to announce the submission of our complete response tothe FDA on February 28th, which is World Rare Disease Day," said SylvieGr©goire, President of Shire HGT. "As an organization we are dedicated tobringing novel therapies for rare diseases to patients; products that can makea positive impact on their lives. We look forward to continued collaborationwith the FDA to bring forward an important new therapeutic option for HAEpatients."
About 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).
FIRAZYR is currently approved in 37 countries worldwide, including the countries of the European Union, for the symptomatic treatment of acute attacks of HAE in adults (with a C1-INH deficiency). 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.
In January 2011, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for a change in the FIRAZYR label in the EU to include self-administered subcutaneous injections in patients who are experiencing acute attacks of HAE.
FIRAZYR is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information.
Important Safety InformationAlmost all subjects who were treated with FIRAZYR in clinical trials developedreactions at the site of injection (characterized by skin irritation, swelling,pain, itchiness, erythema, and burning sensation). Caution should be observedwhen FIRAZYR is administered to patients with acute ischemic heart disease orunstable angina pectoris and in the weeks following a stroke.About HAEHAE is a rare genetic disease. Type I and Type II HAE are caused by low levelsor a dysfunction of C1 esterase inhibitor (C1-INH). Reduced C1-INH activity canlead to elevated plasma levels of bradykinin, the key mediator of HAE symptoms.HAE is characterized by recurrent sudden attacks of edema (swelling) of theskin (hands, arms, feet, legs, thighs, face, genitals) or the mucous membranes(gastrointestinal tract, larynx or voicebox). The swelling can be disfiguringand painful, especially in case of abdominal attacks. Laryngeal attacks arepotentially life-threatening due to the risk of suffocation. Unlike angioedemascaused by allergic reactions, signs and symptoms such as hives and itching donot occur in HAE.Signs and symptoms of HAE do not respond to standardtreatments for allergic angioedema.
For further information please contact:
Investor Eric Rojas [email protected] +1 781 482 0999 Relations Media Jessica Mann [email protected] +44 1256 894 280 Jessica Cotrone [email protected] +1 781 482 9538 Notes to editorsSHIRE PLCShire's strategic goal is to become the leading specialty biopharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on attention deficit hyperactivity disorder (ADHD), humangenetic therapies (HGT) and gastrointestinal (GI) diseases as well asopportunities in other therapeutic areas to the extent they arise throughacquisitions. Shire's in-licensing, merger and acquisition efforts are focusedon products in specialist markets with strong intellectual property protectionand global rights. Shire believes that a carefully selected and balancedportfolio of products with strategically aligned and relatively small-scalesales forces will deliver strong results.
For further information on Shire, please visit the Company's website: www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, the Company's results could be materially adverselyaffected. The risks and uncertainties include, but are not limited to, risksassociated with: the inherent uncertainty of research, development, approval,reimbursement, manufacturing and commercialization of the Company's SpecialtyPharmaceutical and Human Genetic Therapies products, as well as the ability tosecure and integrate new products for commercialization and/or development;government regulation of the Company's products; the Company's ability tomanufacture its products in sufficient quantities to meet demand; the impact ofcompetitive therapies on the Company's products; the Company's ability toregister, maintain and enforce patents and other intellectual property rightsrelating to its products; the Company's ability to obtain and maintaingovernment and other third-party reimbursement for its products; and otherrisks and uncertainties detailed from time to time in the Company's filingswith the Securities and Exchange Commission. Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PXPress Release www.shire.com
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