Genzyme Corp. has launched it’s first commercially available cardiovascular product Cholestagel (colesevelam hydrochloride), in Europe.
Genzyme Corp. launches Cholestagel (colesevelam hydrochloride), it's first commercially available cardiovascular product, in Europe. Cholestagel is a new, non-absorbed, cholesterol-lowering agent aimed at treating patients with primary hypercholesterolemia who cannot meet their targeted cholesterol levels with standard therapies alone.
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. Cholestagel is a polymer in tablet form that lowers LDL (or "bad") cholesterol. It can be taken in combination with other cholesterol-lowering medications, such as statins, or alone. When combined with various statins, fibrates or ezetimibe, current standard treatments for cholesterol control, Cholestagel was shown to have an additive LDL-cholesterol lowering effect in the range of 10 to 16 per cent. A post-approval study launched in August 2007 by Genzyme aims to specifically demonstrate the efficacy of Cholestagel as an add-on therapy in patients with familial hypercholesterolemia (FH) – an inherited disorder that causes exceptionally high levels of LDL-cholesterol – who cannot reach their target LDL-cholesterol levels with a maximum regimen of statins and ezetimibe alone.
Cholestagel is non-systemic, and therefore is not absorbed into the bloodstream. Cholestagel binds bile acids in the intestine, impeding their reabsorption. This process – called bile acid sequestration -results in an increased clearance of LDL cholesterol from the blood. Cholestagel is also well tolerated, with minimal gastrointestinal side effects similar to those seen in placebo, and has limited drug-interaction.
Colesevelam has been approved for use in the United States since 2000, where it is marketed by Daiichi Sankyo Inc. under the trade name WelChol. Genzyme plans to launch Cholestagel in the United Kingdom, the Netherlands and the Scandinavian region this quarter, and in additional European countries next year. Genzyme also intends to pursue regulatory approvals for Cholestagel in Latin America, Canada, and the Asia Pacific region.
Primary hypercholesterolemia comprises a range of disorders in which LDL cholesterol blood levels are above normal (usually above 200mg/dl or 5mmol/l) due to a number of possible genetic mutations such as familial hypercholesterolemia, where patients inherit a gene that prevents them from metabolizing LDL cholesterol properly. These patients face a markedly increased risk of premature cardiovascular disease and CVD-related death.