Vytorin ezetimibe/simvastatin regulatory update

FDA did not approve new indications for 2 cholesterol drugs from Merck in chronic kidney disease (CKD) patients. According to the pharma, the agency did not approve the new indications for Vytorin ezetimibe/simvastatin and Zetia ezetimibe because the Phase III SHARP trial - which formed the basis of the sNDA - was not designed to assess the independent contributions of each drug. Merck does not plan to conduct further trials in the CKD indication. However, FDA did update Vytorin's label to include the SHARP data, which showed Vytorin met the primary endpoint of reducing the incidence of first major vascular events vs. placebo. Vytorin combines the cholesterol absorption inhibitor Zetia and Zocor simvastatin, a HMG- CoA reductase inhibitor.

Last November, an FDA advisory committee voted 16-0 that data support approval of Vytorin to prevent major vascular events in patients with pre-dialysis CKD. However, the panel voted 10-6 that the data do not support approval of the product for end-stage renal disease (ESRD) patients receiving dialysis. The committee's discussion focused only on Vytorin (see BioCentury, Nov. 7, 2011). ...