Zetia/Lipitor combo NDA becomes Merck's latest cardiovascular casualty: FDA refused to file Merck's NDA for a fixed-dose combination pill of ezetimibe (Merck's Zetia) and atorvastatin (Pfizer's Lipitor) known as MK-0653C, the drug maker revealed in a filing with the SEC on Nov. 2. "FDA has identified additional manufacturing and stability data that are needed, and the company is assessing the FDA's response in order to determine a new timetable for filing," Merck said. Ezetimibe, a cholesterol absorption inhibitor, is approved in the fixed-dose combination Vytorin with a different statin, simvastatin (Merck's Zocor and generics), that has faced its share of controversy. The ENHANCE study found that Vytorin was no better than simvastatin alone in preventing the formation of arterial plaque, despite lowering cholesterol (1"The Pink Sheet," April 21, 2008). Other Merck attempts at expanding its cardiovascular franchise have also hit roadblocks, including the heart failure candidate rolofylline, which flunked a Phase III trial in April, and the combination of niacin with the novel anti-flushing agent laropitant, which was deemed "not approvable" in 2008 and is not expected to be refiled until at least 2013 (2"The Pink Sheet" DAILY, June 20, 2008)

Zetia/Lipitor combo NDA becomes Merck's latest cardiovascular casualty: FDA refused to file Merck's NDA for a fixed-dose combination pill of ezetimibe (Merck's Zetia) and atorvastatin (Pfizer's Lipitor) known as MK-0653C, the drug maker revealed in a filing with the SEC on Nov. 2. "FDA has identified additional manufacturing and stability data that are needed, and the company is assessing the FDA's response in order to determine a new timetable for filing," Merck said. Ezetimibe, a cholesterol absorption inhibitor, is approved in the fixed-dose combination Vytorin with a different statin, simvastatin (Merck's Zocor and generics), that has faced its share of controversy. The ENHANCE study found that Vytorin was no better than simvastatin alone in preventing the formation of arterial plaque, despite lowering cholesterol (1"The Pink Sheet," April 21, 2008). Other Merck attempts at expanding its cardiovascular franchise have also hit roadblocks, including the heart failure candidate rolofylline, which flunked a Phase III trial in April, and the combination of niacin with the novel anti-flushing agent laropitant, which was deemed "not approvable" in 2008 and is not expected to be refiled until at least 2013 (2"The Pink Sheet" DAILY, June 20, 2008)

GlaxoSmithKline will reformat data from a trial of its gabapentin prodrug Solzira and resubmit the NDA as quickly as possible, the company says Nov. 10. GSK and partner XenoPort withdrew the NDA after FDA requested a reformatted presentation of data from the study for patients with restless legs syndrome. A 327-patient Phase III trial found a statistically significantly lower proportion of relapses in the treatment group (9 percent) versus the placebo group (23 percent) (1Pharmaceutical Approvals Monthly January 2008, p. 20). The drug would be the first non-dopaminergic agent for the treatment of RLS and would offer potential advantages over GSK's RLS drug Requip