DUBLIN, October 28 /PRNewswire/ -- Shire plc , the global specialty biopharmaceutical company, today announced it has received approval through the European Mutual Recognition Procedure for an extension to the current indication for FOSRENOL(R) (lanthanum carbonate), paving the way to make the non-calcium, non-resin phosphate binder available throughout the EU to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis with a serum phosphorus level greather than or equal to 1.78mmol/L (5.5mg/dL).
The extension was sanctioned by the Swedish Medicines Products Agency as reference member state. Submissions for national marketing authorizations have been made to Sweden and the other 28 European markets with first national approvals anticipated in Q4 2009.
Failure to control phosphate in the earlier stages of chronic kidney disease carries well documented risks, and is associated with reduced bone health and poor cardiovascular outcomes, said Dr. Alastair Hutchison, Manchester Royal Infirmary, UK. The extension to the existing indication for FOSRENOL provides nephrologists in the EU with an important additional option to help tackle the challenge of uncontrolled phosphate at an earlier stage in the progression of kidney disease, before the need for dialysis treatment.
This is an important development in helping CKD patients better manage their elevated phosphate and we are pleased that FOSRENOL is now approved as a treatment option for these patients in the EU, said Gian Piero Reverberi, Senior Vice President, International Specialty Pharmaceuticals, Shire. We are firmly committed to serving the needs of renal patients and ensuring that FOSRENOL is available to the prescribers and patients who can benefit from it.
In relation to the US, Shire continues to evaluate its options for securing a label extension to include CKD patients not on dialysis.
Notes to Editors ABOUT FOSRENOL(R) (lanthanum carbonate) FOSRENOL is indicated: - In the EU as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis. FOSRENOL is also indicated in adult patients with chronic kidney disease not on dialysis with serum phosphate levels greater than or equal to 1.78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.(1) - In the US to reduce serum phosphate in patients with end stage renal disease.(2) - FOSRENOL is not available in all countries and prescribing information may differ between countries. Please consult your local prescribing information.(2) - FOSRENOL works by binding to dietary phosphate in the GI tract; once bound, the lanthanum/phosphate complex cannot pass through the intestinal lining into the blood stream and is eliminated from the body.(1) As a consequence, overall phosphate absorption from the diet is decreased. - FOSRENOL is available in a broad range of dosage strengths including 500mg, 750mg, and 1000mg tablets1 which facilitates an effective dosing regimen of one tablet per meal for the majority of patients. - FOSRENOL was first approved in Sweden in March 2004, and by the US FDA in October 2004. FOSRENOL was subsequently approved in all EU markets by the European Mutual Recognition Procedure and is now launched in 37 markets worldwide. It continues to be approved and made available in new markets around the world. Important Safety Information - Patients with renal insufficiency may develop hypocalcaemia. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given. - No data are available in patients with severe hepatic impairment. Caution should, therefore, be exercised in these patients, as elimination of absorbed lanthanum may be reduced. - FOSRENOL should not be used during pregnancy. - Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with FOSRENOL. - The most commonly reported Adverse Drug Reactions are gastrointestinal reactions, such as abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting. These are minimized by taking FOSRENOL with food and generally abate with time with continued dosing. Hypocalcaemia was the only other commonly reported adverse reaction. Full prescribing information is available on request.
(1) Shire plc. FOSRENOL EU SmPC. Last revised September 2009.
(2) Shire plc. FOSRENOL US PIL. Last revised April 2008.
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: http://www.shire.com.
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Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.
SOURCE: Shire Plc
CONTACT: For further information please contact: Media: Jessica Mann (Restof the World), +44-1256-894-280; Matthew Cabrey (North America, SpecialtyPharma), +1-484-595-8248; Con Franklin, Resolute Communications (ex-US),+44-207-015-1354; Caren Weintraub, Resolute Communications (US),+1-212-213-8181