Atorvastatin Treatment IND Approved

The US Food and Drug Administration has approved a treatment Investigational New Drug application for Warner-Lambert's HMG-CoA reductase inhibitor, atorvastatin, for the treatment of patients with homozygous familial hypercholesterolemia.

To be eligible for the program, patients must have the disorder or an LDL level greater than 220mg/dl. Patients must also have undergone treatment with the maximum tolerated dose of lipid-lowering agents and have a less than 15% lipid-lowering response while on therapy.

According to the company, a 60% reduction in LDL-C occurs at a dose of 50mg/day of the drug. A 40% reduction in LDL occurs with a dose of 40mg/day of simvastatin and with a dose of approximately 80mg/day of lovastatin (Merck & Co's Mevacor) or pravastatin (Bristol-Myers Squibb's Pravachol).