FDAnews Drug Daily Bulletin

Schering-Plough is reinforcing the mantra that lower low-density lipoprotein (LDL) cholesterol levels are healthier as the firm reacts to the initial wave of declining prescriptions for its joint venture cholesterol franchise, Vytorin.

When Schering-Plough and partner Merck released results from the drug’s ENHANCE trial, total weekly prescriptions declined for the franchise. However, that trend appears to have stabilized, and significant prescription declines outside the U.S. have not been observed, Schering-Plough Chief Financial Officer Robert Bertolini said during the company’s year-end earnings call Tuesday.

The results of the ENHANCE trial confirmed that Vytorin reduced LDL cholesterol levels more than simvastatin alone in patients with heterozygous familial hypercholesterolemia. But there was no significant difference between the drugs in reducing atherosclerotic plaques in inner walls of carotid arteries. This could potentially raise doubts about whether lower LDL is better.

Schering-Plough CEO Fred Hassan disagreed. “It’s a small study in a rare population using a novel ultrasound scanning technology,” he said. “Nothing has really changed in terms of the lower LDL is better proposition.”

Vytorin is marketed as lowering LDL cholesterol levels more than Lipitor or AstraZeneca’s Crestor (rosuvastatin calcium) alone.