- FOSRENOL(R) (lanthanum carbonate) Now Approved in the EU to Treathyperphosphataemia >1.78mmol/L in Chronic Kidney Disease Patients Not onDialysis
Shire plc SHPSHPGY, the global specialtybiopharmaceutical company, today announced it has received approval throughthe European Mutual Recognition Procedure for an extension to the currentindication for FOSRENOL(R) (lanthanum carbonate), paving the way to make thenon-calcium, non-resin phosphate binder available throughout the EU tocontrol hyperphosphataemia in chronic kidney disease (CKD) patients who arenot on dialysis with a serum phosphorus level greather than or equal to1.78mmol/L (5.5mg/dL).
The extension was sanctioned by the Swedish Medicines Products Agency asreference member state. Submissions for national marketing authorizationshave been made to
"Failure to control phosphate in the earlier stages of chronic kidneydisease carries well documented risks, and is associated with reduced bonehealth and poor cardiovascular outcomes," said Dr.
"This is an important development in helping CKD patients better managetheir elevated phosphate and we are pleased that FOSRENOL is now approved asa treatment option for these patients in the EU," said
In relation to the US, Shire continues to evaluate its options forsecuring a label extension to include CKD patients not on dialysis.
Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit hyperactivitydisorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)diseases as well as opportunities in other therapeutic areas to the extentthey arise through acquisitions. Shire's in-licensing, merger and acquisitionefforts are focused on products in specialist markets with strongintellectual property protection and global rights. Shire believes that acarefully selected and balanced portfolio of products with strategicallyaligned 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.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORMACT OF 1995
Statements included herein that are not historical facts areforward-looking statements. Such forward-looking statements involve a numberof risks and uncertainties and are subject to change at any time. In theevent such risks or uncertainties materialize, the Company's results could bematerially adversely affected. The risks and uncertainties include, but arenot limited to, risks associated with: the inherent uncertainty of research,development, approval, reimbursement, manufacturing and commercialization ofthe Company's Specialty Pharmaceutical and Human Genetic Therapies products,as well as the ability to secure and integrate new products forcommercialization and/or development; government regulation of the Company'sproducts; the Company's ability to manufacture its products in sufficientquantities to meet demand; the impact of competitive therapies on theCompany's products; the Company's ability to register, maintain and enforcepatents and other intellectual property rights relating to its products; theCompany's ability to obtain and maintain government and other third-partyreimbursement for its products; and other risks and uncertainties detailedfrom time to time in the Company's filings with the Securities and ExchangeCommission.
SOURCE Shire Plc
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