FDA Approves Genzyme's Renvela for Dialysis Patients
Genzyme today announced that the U.S. Food and Drug Administration has granted marketing approval for Renvela™ (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Renvela is a next-generation version of Renagel® (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States.
"Since its approval in 1998, Renagel has made an important difference for hundreds of thousands of patients around the world. Today's approval of Renvela – an improved form of Renagel – is a key milestone in our ongoing effort to innovate on behalf of patients," said John P. Butler, president, Genzyme Renal. "As we prepare to launch Renvela for patients on dialysis, we will move forward with regulatory filings to gain approval for the product's use in earlier stages of chronic kidney disease, so that all patients who can benefit from this treatment have access to it."
Like Renagel, Renvela is a calcium-free, metal-free, non-absorbed phosphate binder and will initially be available as 800mg tablets. Renvela offers all of the advantages of Renagel with the added benefit of a carbonate buffer. In a clinical study comparing Renvela to Renagel, both drugs controlled serum phosphorus equally to within KDOQI recommended ranges. Patients on Renvela, however, were more likely to maintain bicarbonate levels within the recommended KDOQI ranges, and had a lower incidence of gastrointestinal adverse events.
Genzyme expects to launch Renvela for dialysis patients in the United States during the first quarter of next year, and is pursuing regulatory approvals in Europe, South America and in other markets internationally. The company will continue to make Renagel available, with the long-term goal of transitioning patients to Renvela.
"Renvela's approval represents an important advance for chronic kidney disease patients," stated Craig Langman, M.D., the Isaac A. Abt M.D. professor of kidney diseases, Feinberg School of Medicine, Northwestern University. "It is an improved version of a well-established product that has been shown to provide significant advantages to patients."
During the first half of next year, Genzyme also plans to file a supplemental New Drug Application with the FDA seeking approval of Renvela for hyperphosphatemic patients with chronic kidney disease who are not on dialysis. In addition, Genzyme expects to file for approval of a powder form of Renvela that may make it easier for patients to comply with their prescribed treatment program.
Renagel in Peritoneal Dialysis
The FDA also recently approved a label extension for Renagel for the control of serum phosphorus for patients on peritoneal dialysis. The treatment had previously been approved in the U.S. only for patients on hemodialysis. The Renvela approval announced today includes patients on both types of dialysis.
About Renagel and Renvela
Renagel (sevelamer hydrochloride) and Renvela (sevelamer carbonate) both control serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Controlling serum phosphorus is an important element in the care of dialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular morbidity and mortality. Sevelamer provides the added benefit of significant LDL cholesterol reduction.
Sevelamer is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation. The National Kidney Foundation’s 2003 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for Bone Metabolism and Disease in CKD recommend sevelamer as a first-line treatment option to control phosphorus. Sevelamer hydrochloride is currently used by more than 350,000 patients worldwide.
Product Information
Renvela is indicated for the control of serum phosphorus in patients with CKD on dialysis. Renvela is contraindicated in patients with hypophosphatemia or bowel obstruction. Caution should be exercised in patients with dysphagia, swallowing disorders, severe gastrointestinal (GI) motility disorders including severe constipation, or major GI tract surgery. The most common adverse events included vomiting, nausea, diarrhea, and dyspepsia. Drug-drug interactions may occur with some medications and should be taken into consideration when instructing patients how to take Renvela. Please see prescribing information at http://www.genzyme.com/corp/investors/Renvela_PI.pdf. For additional information, please visit www.renvela.com.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with nearly 10,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for†in the United States.
With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.
This press release contains forward-looking statements, including the statements regarding Genzyme’s intention to move forward with regulatory filings to gain approval for use of Renvela™ in earlier stages of chronic kidney disease, the initial availability of the 800mg tablet formulation of Renvela™, Genzyme’s expectations with respect to timing of commercial launch of Renvela™, its pursuit of regulatory approvals in Europe, South America and other markets, the continued availability of Renagel®, Genzyme’s plans to file a supplemental New Drug Application with the FDA seeking approval of Renvela™ for hyperphosphatemic patients with chronic kidney disease who are not on dialysis and Genzyme’s expectation that it will seek approval of a powder form of Renvela™. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the inability or delay of getting regulatory approvals for future label extensions of Renvela™, the logistical risks associated with manufacturing and formulating the product, delays or unexpected problems with commercial launch of Renvela™, the medical community’s acceptance of this new product, the transition from Renagel® to Renvela™, the ability to get marketing approvals in other countries, the ability to get favorable pricing and reimbursement for Renvela™, the ability to get approvals of an alternative formulation such as the powder form of Renvela™. There are also risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Risk Factors" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending June 30, 2007. Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.