US drug major Merck & Co plans to discontinue the ACHIEVE imaging study, which is evaluating MK-0524A (ER niacin/laropiprant) in patients with heterozygous familial hypercholesterolemia (Marketletter May 5). The firm said the decision was based on the recommendation of the trial's steering committee after it reviewed and evaluated scientific data from recent carotid intima-media thickness studies. Merck stressed that the move is not related to the recent US "not approvable" letter on MK-0524A, and preliminary data did not suggest any safety concerns. "It was clear...that the patient population being studied in ACHIEVE was no longer the correct population to test the primary study hypothesis of IMT progression," said John Kastelein, chair of the ACHIEVE steering committee. MK-0524A has predicted peak annual sales of $600.0 million. On the day this new delay was announced, May 21, shares in Merck fell 1.5% to $39.13.
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