- The approval is based on the P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. with HoFH for 24wks.
- The study met 1EPs i.e. 49% reduction in LDL-C (47% vs 2%), patients also experienced a reduction in the level of ApoB, non-HDL-C. Reductions in LDL-C were observed as early as weeks 2 and maintained throughout week 24 and the open-label trial period (through week 48).
- Evinacumab is a mAb targeting ANGPTL3 and is under FDA’s PR following the BTD granted in 2017
Click here to read full press release/ article | Ref: PRNewswire | Image: Barron’s