* Second interim analysis of IMPROVE-IT trial delayed
* Merck CFO says delay is due to scheduling event
* Says delay will not affect overall review time
Sept 13 (Reuters) - Merck & Co (MRK.N) said on Tuesday an interim analysis of a clinical trial of its cholesterol drug Vytorin will be delayed, though the company’s chief financial officer said the delay would not affect the overall timing of its regulatory review.
Whitehouse Station, New Jersey-based Merck said the executive committee overseeing a trial known as IMPROVE-IT has scheduled the study’s second interim analysis for the first quarter of 2012, rather than late 2011, as previously anticipated.
Peter Kellogg, Merck’s CFO, said at the Morgan Stanley global healthcare conference that the delay is purely one of scheduling and will not affect overall timing of the trial, expected to be complete in 2013.
“That has not been part of the discussion so far,” he said.
Vytorin is a pill that combines two cholesterol-lowering drugs — Zocor, or simvastatin, and Zetia, or ezetimibe. It has been dogged by safety concerns for several years.
The IMPROVE-IT trial is testing whether Vytorin reduces major heart heart problems in patients with acute coronary syndrome, a term that describes chest pains, unstable angina and other symptoms caused by a sudden reduction in blood flow to the heart. The trial compares Vytorin to Zocor alone. (Reporting by Toni Clarke in Boston and Michele Gershberg in New York, editing by Dave Zimmerman)