The Canadian regulatory authority Health Canada has approved Valeant Pharmaceuticals' New Drug Submission of colesevelam hydrochloride (colesevelam).
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Colesevelam, an orally administered, bile-acid sequestrant showed efficacy in reducing LDL-C lipoproteins and drug-interaction and tolerability profile comparable to placebo.
Valeant chairman and CEO Michael Pearson said clinical trials have shown reduced cardiovascular events with the use of bile acid sequestrants, either as monotherapy or in combination with other agents.
"Compared with conventional bile acid sequestrants, colesevelam has enhanced specificity, greater affinity, and higher capacity for binding bile acids, due to its polymer structure engineered for bile acid sequestration," Pearson said.
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