Shire Files Complete Response to FDA's Not Approvable Letter for FIRAZYR(R) (icatibant) for the Treatment of Acute Attacks of Hereditary AngioedemaBy Shire Plc, PRNE
Sunday, February 27, 2011
DUBLIN and LEXINGTON, Massachusetts, February 28, 2011 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that it has submitted a complete
response to the not approvable letter issued by the US Food and Drug
Administration (FDA) to Jerini AG in April 2008 regarding its New Drug
Application for FIRAZYR(R) (icatibant) for the treatment of acute attacks of
hereditary angioedema (HAE). Once the FDA acknowledges receipt of the file, a
timeline for completing the review of this Class II resubmission will be
communicated to Shire.
Shire's complete response includes additional data requested by the
agency regarding FIRAZYR's efficacy and safety in treating HAE attacks. Shire
conducted an additional Phase III clinical study (FAST-3), and in December
2010 reported positive efficacy and safety results (
www.shire.com/shireplc/en/media/shirenews?id=431). The Company's
complete response is based primarily on recent results from the FAST-3 study
and the ongoing self-administration study, as well as the previously
published FAST-1 and FAST-2 studies.
"It is very rewarding to announce the submission of our complete response
to the FDA on February 28th, which is World Rare Disease Day," said Sylvie
Grégoire, President of Shire HGT. "As an organization we are dedicated to
bringing novel therapies for rare diseases to patients; products that can
make a positive impact on their lives. We look forward to continued
collaboration with the FDA to bring forward an important new therapeutic
option for HAE patients."
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
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 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.
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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For further information please contact:
Investor Relations Eric Rojas (email@example.com) +1-781-482-0999 Media Jessica Mann (firstname.lastname@example.org) +44-1256-894-280 Jessica Cotrone (email@example.com) +1-781-482-9538
Investor Relations: Eric Rojas, ( erojas at shire.com ), +1-781-482-0999 ; Media: Jessica Mann, ( jmann at shire.com ), +44-1256-894-280; Jessica Cotrone, ( jcotrone at shire.com ), +1-781-482-9538
Tags: Dublin And Lexington, February 28, ireland, Massachusetts, Shire Plc