ADCOM QUESTION ONNNNN
DISCUSSION: Please discuss your interpretation of the efficacy results from the REDUCEIT Trial, including the following:
a. Overall strengths and limitations of the data, including the use of a single trial to
support a first-in-class cardiovascular outcomes indication and robustness of the
results
b. Confidence in the trial outcomes when considering the mineral oil placebo
c. Magnitude/clinical relevance of the observed treatment effect
d. Components of the primary composite endpoint or secondary endpoints, including the
robustness of the data to support an indication for CV death
2. DISCUSSION: Please discuss your level of concern about the new safety findings (increased
risk of atrial fibrillation/atrial flutter and bleedings events) from the REDUCE-IT trial and
whether labeling can reasonably manage these risks.
3. DISCUSSION: The applicant has proposed an indication for cardiovascular risk reduction in
adult patients with triglyceride levels greater than 135 mg/dL and additional risk factors for
cardiovascular disease (CVD), without regard for age, diabetes status, or adequacy of lowdensity lipoprotein (LDL-C) control. Please discuss the population – beyond the subset of
patients with established CVD – for whom you believe the data from REDUCE-IT provide
evidence of cardiovascular risk benefit, addressing the following factors:
• Age
• Diagnosis of diabetes
• Additional risk factors for CVD
• Plasma LDL-C concentration
• Plasma triglyceride concentration
• Intensity of statin therapy
• Any other factor you believe is important
4. VOTE: Has the applicant provided sufficient evidence of efficacy and safety to support the
approval of Vascepa for an indication to reduce the risk of cardiovascular events?
a. If yes, provide your recommendations regarding the indicated population and
components of the primary endpoint to include in labeling.
b. If no, provide your rationale and comment on what additional data would be needed to
support approval.
