Genzyme General, a division of Genzyme Corp., has filed with European regulatory authorities for approval to market Cholestagel (colesevelam hydrocholoride), a novel, non-absorbed cholesterol-lowering agent for the treatment of primary hypercholesterolemia (elevated cholesterol). The European Marketing Authorization Application (MAA) requests the approval of Cholestagel both as a monotherapy and in combination with HMG-CoA reductase inhibitors ("statins").
Genzyme submitted the MAA to the European Agency for the Evaluation of Medicinal Products (EMEA) on August 30, 2002. The agency has accepted the MAA and validated that it is complete and ready for scientific review. The EMEA''s Committee for Proprietary Medicinal Products (CPMP) will now evaluate the application to determine whether to approve Cholestagel in all 15 member states of the European Union. The final commission decision is expected by the end of 2003.
Colesevelam hydrochloride has been marketed in the United States under the brand-name Welchol for two years by Genzyme General''s U.S. marketing partner for the product, Sankyo Pharma Inc.
Since the mid-1980s, elevated cholesterol has been widely recognized as a significant risk factor for coronary heart disease. As a result of the increased awareness and the broad prevalence of elevated LDL cholesterol, cholesterol-reducing drugs have emerged as one of the largest and fastest growing pharmaceutical product categories.
Colesevelam hydrochloride is a non-absorbed, lipid-lowering agent specifically engineered to efficiently bind bile acids in the intestine, impeding their reabsorption. This process - called bile acid sequestration - initiates a series of events that results in an increased clearance of LDL (or "bad") cholesterol in the blood. Colesevelam hydrochloride''s ability to lower serum LDL cholesterol levels was demonstrated in eight clinical trials with approximately 1,600 patients and treatment durations ranging from 4 to 50 weeks. Those trials also demonstrated the product''s ability to increase levels of HDL (or "good") cholesterol. The product was found to be effective as a monotherapy for patients with mild to moderate hypercholesterolemia. In combination studies of the product with a leading statin, results show the two work better together than either one alone. The studies were conducted with atorvastatin (Lipitor), lovastatin (Mevacor) or simvastatin (Zocor).
WelChol, available in the United States by prescription only, effectively lowers LDL cholesterol (or "bad" cholesterol) by an average of 15-18% (depending on dose) and is the only lipid-lowering agent that is FDA-approved for combination use with any dose of any statin. Administered alone or in combination with a statin, WelChol is indicated as adjunctive therapy to diet and exercise for the reduction of elevated cholesterol in patients with primary hypercholesterolemia when diet and exercise alone are not adequate. The effects of WelChol either alone or with a statin on cardiovascular morbidity and mortality have not been determined.