YB, the "new" science wouldn't disagree with his statement.
"The active moiety in GlaxoSmithKline’s Lovaza, a similar agent for the treatment of hypertriglyceridemia, is a mixture of omega-3-acid ethyl esters that includes icosapent ethyl (EPA), docosahexaenoic acid (DHA), and a few others. Without requiring GlaxoSmithKline to specify which ester helps to lower triglycerides, the FDA considered the mixture of EPA and DHA as the active moiety that is responsible for the physiological and pharmacological action of Lovaza. Vascepa might have an advantage over Lovaza; it does not increase LDL-C levels, which has sometimes been observed with Lovaza.
The FDA considers Vascepa to be a new chemical entity. It contains only EPA but not DHA, and it does not contain any appended portions of both EPA and DHA that cause them to be an ester, salt, or other non-covalent derivative. Therefore, its active moiety has not been previously approved by the FDA in any other application submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act."
He made no comment that the FDA considered Icosapent Ethyl, a prodrug...he may have not had access to the Medical Review document at the time of his statement. Also, it's likely he knew nothing of the 2D & 3D variation potential in the two EPA molecules. I suspect the EPA is a homogeneous mix of "cis EPA" in Vascepa, While Lovaza's mix is more heterogeneous with possible variances in EPA structure from different fish sources. (Just speculation though)
His statement is general and makes perfect sense, if the new science theory is correct, it makes perfect science and a crystal clear NCE decision.
Williams
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