EMEA Rejects Pediatric Vytorin

The European Medicine Agency’s (EMEA) Paediatric Committee has decided not to recommend use of Vytorin and a related treatment that Merck submitted for treating high cholesterol in children.

The cholesterol drugs “do not represent a significant therapeutic benefit over existing treatments,” the EMEA says in a statement.

The decision is the latest setback on Vytorin (ezetimibe/simvastatin) for Merck, which does business in Europe as Merck Sharp & Dohme. The drugmaker markets Vytorin through a joint venture with Schering-Plough. The other treatment rejected by the EMEA is comprised of nicotinic acid (also known as niacin or vitamin B3) in an extended-release form combined with Zocor (simvastatin) and laropiprant.

Recently, two congressmen asked the FDA to release a new study they say links Vytorin to cancer.