European Commission Approves Self-Administration Label for FIRAZYR(R) (icatibant) for the Symptomatic Treatment of Acute Hereditary Angioedema AttacksBy Shire Plc, PRNE
Wednesday, March 2, 2011
DUBLIN and LEXINGTON, Massachusetts, 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 naive and non-naive 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
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.
Important Safety Information
Almost all subjects who were treated with FIRAZYR in clinical trials
developed reactions at the site of injection (characterized by skin
irritation, swelling, pain, itchiness, erythema, and burning sensation).
Caution should be observed when FIRAZYR is administered to patients with
acute ischemic heart disease or unstable angina pectoris and in the weeks
following a stroke.
HAE is a rare genetic disease. Type I and Type II HAE are caused by low
levels or a dysfunction of C1 esterase inhibitor (C1-INH). Reduced C1-INH
activity can lead to elevated plasma levels of bradykinin, the key mediator
of HAE symptoms.
HAE is characterized by recurrent sudden attacks of edema (swelling) of
the skin (hands, arms, feet, legs, thighs, face, genitals) or the mucous
membranes (gastrointestinal tract, larynx or voicebox). The swelling can be
disfiguring and painful, especially in case of abdominal attacks. Laryngeal
attacks are potentially life-threatening due to the risk of suffocation.
Unlike angioedemas caused by allergic reactions, signs and symptoms such as
hives and itching do not occur in HAE. Signs and symptoms of HAE do not
respond to standard treatments for allergic angioedema.
For further information and sources of support for HAE, please visit the
international patient organization, Hereditary Angioedema International, at
Notes to editors
Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit hyperactivity
disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases as well as opportunities in other therapeutic areas to the extent
they arise through acquisitions. Shire's in-licensing, merger and acquisition
efforts are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire believes that a
carefully selected and balanced portfolio of products with strategically
aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company's website:
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