Page 11 of briefing doc:
During the review of the MARINE data, the Division noted that several lipid parameters
(including TG) increased from baseline to week 12 in the placebo group, treated with mineral oil.
The available literature regarding potential effects of mineral oil was considered. Similar
increases in TG levels observed in the placebo groups from the Lovaza (omega-3 EE) clinical
trials of hypertriglyceridemic patients were noted, and these trials did not use a mineral oil placebo. Because no strong evidence for biological activity of mineral oil was identified,
ultimately it was concluded that the between-group differences likely provided the most
appropriate descriptions of the treatment effect of AMR101 and that whatever factor(s) led to the
within-group changes over time in the placebo group were likely randomly distributed to all
treatment groups. Taken together, along with the statistical robustness in primary and sensitivity
analyses of AMR101 4g/day on TG lowering, the Division concluded that AMR101 4g/day is an
effective TG-lowering agent for patients with severe hypertriglyceridemia. AMR101 was
approved for the following treatment indication on July 26, 2012: