Merck/S-P's Zetia gets expanded US label

US drugmakers Merck & Co and Schering-Plough Pharmaceuticals say that the Food and Drug Administration has approved their co-developed dyslipidemia drug Zetia (ezetimibe) for use in combination with fenofibrate for the reduction of elevated total cholesterol, as well as low-density lipoprotein cholesterol, in patients with mixed hyperlipidemia when diet alone is not enough.

The new condition is characterized by elevated levels of both LDL cholesterol and triglycerides, as well as reduced levels of the beneficial high-density lipoprotein cholesterol. It represents a signifcant label expansion for the agent, which was previously only cleared for the treatment of high LDL cholesterol resistant to exercise and diet changes.

Despite the fact that this increases Zetia's potential sales, Merck shares fell $0.10 to $33.87 on June 9, the day of the announcement, while shares in Schering-Plough inched up $0.08 to $19.53.