Newswise — Shire Pharmaceuticals Group plc (NASDAQ: SHPGY, LSE: SHP.L, TSE: SHQ CN) announced today that the United States Food and Drug Administration (FDA) has approved FOSRENOL (R) (lanthanum carbonate), a non-calcium, non-aluminum phosphate binder that reduces high phosphorus levels in end-stage renal disease (ESRD) patients. FOSRENOL will be available in the U.S. within the next few months.
Even with a low phosphorus diet, most ESRD patients in the U.S. will develop hyperphosphatemia (high phosphorus levels in the blood). Without effective treatment, hyperphosphatemia may lead to renal osteodystrophy, a collection of bone diseases characterized by bone pain, brittle bones, skeletal deformities and fractures. Accumulating evidence also shows that hyperphosphatemia may contribute to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients.
"The FDA approval of FOSRENOL represents an important milestone option for ESRD patients and their health care providers, because fewer than one-third are able to achieve serum phosphorus control despite dietary restriction and medication therapy," said Dr. Eliseo Salinas, Shire's Chief Scientific Officer and Executive Vice President of Global Research & Development. "FOSRENOL is an effective and generally well-tolerated phosphate binder with a potential for a low pill burden. It will provide patients and health care providers with a new option to achieve phosphorus control and help manage hyperphosphatemia."
In clinical trials involving ESRD patients treated with FOSRENOL, reductions in serum phosphorus were noted one week after starting therapy and the majority of patients reached target levels within eight weeks per the clinical trial design. Maintenance of reduction has been observed for up to three years in patients treated with FOSRENOLâ in long-term, open-label extensions.
In long-term open-label studies, 14 percent of the FOSRENOL-treated patients dropped out due to adverse events. Additionally, bone biopsies taken from patients who had been treated with FOSRENOL for up to two years, showed that patients maintained their bone health status throughout the course of treatment.
FOSRENOL is formulated as an easy to use, chewable only tablet that can be taken without water, an important advantage for ESRD patients who must restrict their fluid intake. FOSRENOL will be available in 250 milligram (mg) and 500 mg strengths. The recommended initial daily dose of FOSRENOL is 750 to 1,500 mg for adults; physicians should adjust the dose to reach target serum phosphorus levels. Most patients require a total daily dose between 1,500 mg and 3,000 mg to achieve serum phosphorus control, which equates to one to two FOSRENOLâ tablets per meal. The daily dose should be divided and taken with meals and snacks.
"Maintaining ESRD patients' serum phosphate levels within a normal range has been very challenging because phosphorus is continually being absorbed into the body from food, and dialysis does not completely eliminate it from patients' blood," said William F. Finn, M.D., professor of medicine at the University of North Carolina School of Medicine at Chapel Hill. "FOSRENOL has been shown to be effective and well-tolerated in clinical studies, and is likely to aid in simplifying the management of hyperphosphatemia for patients and physicians."
Earlier this year regulatory authorities in Sweden granted marketing authorization for FOSRENOL. As Sweden is the reference member state in the European Union Mutual Recognition Procedure for FOSRENOL, this approval was the first step in securing marketing approval throughout Europe. Shire has out-licensed the rights to develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd.
Managing Hyperphosphatemia Phosphorus, an element found in nearly all foods, is absorbed from the gastrointestinal tract into the bloodstream. When the kidneys fail, they no longer effectively remove phosphorus, even with the help of blood-cleansing dialysis machines. While the normal adult range for phosphorus is 2.5 to 4.5 mg/dL, the blood phosphorus levels of many patients on dialysis exceed 6.5 mg/dL. Such levels have been linked to a significantly higher illness and death risk for patients who have undergone at least one year of dialysis.
Of the approximately 20 million Americans who have some form of kidney disease, as of 2002, more than 512,000 have developed ESRD, a figure that has grown 400 percent over the last 20 years.
Diet restrictions alone generally cannot control phosphorus levels and patients traditionally manage hyperphosphatemia by taking phosphorus-binding agents at every meal and snack. Such binders "soak up" phosphorus in the gastrointestinal tract, before it can be absorbed into the blood. Despite the availability of these agents, it remains a challenge for some ESRD patients to maintain target ranges. According to the National Kidney Foundation's new Kidney Disease Outcomes Quality Initiative (K/DOQI) Clinical Practice Guidelines for Bone Metabolism and Disease, Guideline 3, Evaluation of Serum Phosphorus Levels, fewer than 30 percent of dialysis patients are able to maintain serum phosphorus levels in the target range.
The K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease also note in Guideline 5, Use of Phosphate Binders in Chronic Kidney Disease (CKD), that non-calcium and non-aluminum phosphate binders are a preferred first-line treatment option in lowering serum phosphorus levels. Because FOSRENOLâ does not contain calcium or aluminum, it meets the K/DOQI recommendations as one of the preferred first-line treatment options in lowering serum phosphorus levels.
FOSRENOLFOSRENOL works by binding to dietary phosphorus in the upper gastrointestinal tract. Once bound, the FOSRENOL/phosphorus complex cannot pass into the bloodstream and is eliminated from the body. Consequently, a patient's overall absorption of phosphorus from the diet significantly decreases.
Shire has conducted an extensive clinical research program for FOSRENOL involving more than 2,000 patients, some of whom have been treated for up to 36 months. In clinical trials, FOSRENOL was generally well-tolerated.
Please see attached full prescribing information.
Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently has a range of projects and products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal disease. Shire has operations in the world's key pharmaceutical markets (U.S., Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the U.S. For further information on Shire, please visit the Company's Web site: http://www.shire.com, or the FOSRENOLâ Web site: http://www.FOSRENOL.com.
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
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, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact on Shire's Attention Deficit Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to the expected product approval dates of METHYPATCH® (methylphenidate), XAGRID® (anagrelide hydrochloride) and BIPOTROL® (carbamazepine), the implementation of Shire's planned reorganization and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including Shire's most recent annual report on Form 10-K.
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