I was just checking the data on safety here
.A total of 12 deaths occurred in patients who received VDZ; the FDA reviewer concluded that none of those deaths were related to VDZ.
In the comparative safety data, infections were higher overall in the VDZ group than the placebo (PBO) group (43% vs 35%), but serious infections were about the same across groups (4% in VDZ, 3% in PBO, and 3% in VDZ/PBO).
Upper respiratory tract infections were the most frequently reported infections (high-level term; 24% VDZ vs 17% PBO) and appear to have driven the difference in frequency of overall infections between the VDZ and PBO groups.
Herpes viral infections (none serious) were reported by 51 patients; most were oral herpes. Herpes infection rates were similar between the treatment groups (3% VDZ/PBO, 2% PBO, and 3% VDZ).
Not bad, initially. We'll see how this pans out.
Good to note about
the PML deaths given Tysabri's history.