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Sanofi And Regeneron Leapfrog Amgen In New Cholesterol Drug Race

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Early on Monday Sanofi and Regeneron leapfrogged their rival Amgen to gain leadership in the race to bring a new class of cholesterol drugs to market. The new development could potentially give Sanofi and Regeneron a month on the market by itself before facing competition from Amgen.

Sanofi and Regeneron announced early on Monday that the FDA had accepted for priority review the Biologics License Application (BLA)

for alirocumab, their PCSK9 inhibitor.  The six month priority review prescribed by the Prescription Drug User Fee Act (PDUFA) yields a target action date of July 24, 2015. The drug, a monoclonal antibody, will be marketed under the brand name of Praluent.

Last November Amgen announced that the FDA had accepted the BLA for its rival PCSK9 inhibitor, evolocumab, and had set a PDUFA target action date of August 27, 2015. In the early stages of the race Amgen had been thought to be ahead in the race. But Sanofi and Regeneron stepped on the gas and accelerated their development program. Then last summer Sanofi and Regeneron appeared to gain the lead when, in a surprising move, they purchased from another company a priority review voucher, cutting their FDA review time to 6 months.

Both drugs are being evaluated in people at high risk for cardiovascular events who are unable to tolerate statins or who have persistent high cholesterol levels despite taking a statin, including people with familial hypercholesterolemia. The drugs have been shown to be highly effective at lowering LDL cholesterol levels but the final results from ongoing cardiovascular outcome studies will not be finished for several more years. Promising preliminary results from the ongoing Odyssey trials were presented last November. In March Amgen will present its own preliminary outcomes findings.

Both drugs have also been accepted for review by the European Medicines Agency.

Commercial expectations are large for the PCSK9 inhibitors, though much about the drugs remains unclear, including their price, the willingness of people to take regular injections, and the precise language of the label. Analysts and other observers have predicted that the drugs will gain approval, but there remains the possibility that FDA reviewers or panel advisory members could block or slow the PCSK9 inhibitor steamroller.