sts - they did not ask for a label without statins - I think it is assumed in the document language that it is with statins. Anyone else think differently?
"The applicant is seeking an indication for Vascepa as an adjunct to statin therapy in adult patients with elevated triglyceride levels (TG >135 mg/dL) and other risk factors for CVD, but the trial inclusion criteria and data do not appear to support such a broad population. "
In my opinion the FDA's issue is this:
"The applicant’s proposed indicated population is notably silent on several issues including appropriate patient age, presence of established CVD, presence of diabetes in patients without established CVD, statin intensity, and resulting LDL-C levels on therapy."
***The trial had pre-specified requirement for LDL <100 and JT wants a label that doesn't have specify the level of LDL. They are saying, if LDL is above 100, statins should be used to get LDL below 100 before using V.
Page 48:
"In summary, the trial population represents a higher risk group than the proposed indicated population, encompassing patients with diabetes and additional risk factors, and hypertriglyceridemia despite optimized statin therapy. There is no evidence in REDUCE-IT that AMR101 is the appropriate therapy in lower-risk patients who may have elevated LDL-C in addition to mild hypertriglyceridemia and who would benefit from optimization of statin therapy first."
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