Amarin’s Vascepa May Give Lovaza A Run For Its Money
This article was originally published in The Pink Sheet Daily
Label for Amarin’s EPA-only omega-3 fatty acid therapy notes that in patients with really high triglycerides, triglycerides are lowered significantly with no increase in bad cholesterol, a potential differentiating point from Pronova/Glaxo’s blockbuster EPA/DHA therapy Lovaza. But contrary to what Amarin wanted, data from a study in healthier patients doesn’t make it into labeling.
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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.
FDA leaves door open to modify label of Amarin’s omega-3 fatty acid therapy Vascepa prior to approval in a healthier population, says company CEO. Per the current label, triglycerides are lowered significantly with no increase in LDL cholesterol, a potential differentiating point from Pronova/Glaxo’s blockbuster EPA/DHA therapy Lovaza.
Bad News/Good News For Cholesterol: Another Strike Against HDL, But Support For Stricter LDL Targets
A large genetic analysis published in the Lancet suggests that drugs that raise HDL may not reduce cardiovascular risk, creating more bad news for a field still reeling from the failure of Roche’s dalcetrapib. But another study calls for much wider use of LDL-lowering drugs, even in patients with low cardiovascular risk.