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Cholesterol Drug Approvals May Hinge On Outcomes Studies; FDA Rejects Diabetes-style Tiered Trials

Executive Summary

Decreasing cardiovascular events is the only endpoint that matters for cholesterol-lowering drugs, FDA official says at Amarin’s negative Vascepa panel, leaving little room for drug’s expanded approval based on a surrogate endpoint.

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AstraZeneca’s Epanova: Third In Omega-3 Market, Potentially First With Larger Population Claim

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Targeting Inflammation In Atherosclerosis After Darapladib: Does The IL-6 Pathway Hold The Answer?

Targeting inflammation appears to be a promising complementary approach to lipid-lowering drugs in atherosclerosis, but the question of which pathway in a complex system to target remains open. The failure of GlaxoSmithKline’s darapladib in the STABILITY trial may have dealt a fatal blow to phospholipase A2 enzymes as targets, but the interleukin-6 pathway is gaining attention with the ongoing CANTOS study of Novartis’ canakinumab and the NHLBI’s CIRT study of low-dose methotrexate.

Omega-3 Questions Could Pull Plug On Sales Growth

Pharma firms’ introduction and wide promotion of Rx drugs containing EPA or DHA acids and aimed at improving cardiovascular health were expected to boost omega-3 supplement sales, but negative research results reported over the past year could diminish consumers’ regard for the nutrients’ benefits.

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