Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia

February 12, 2021 Auto Bot approval, FDA, patients, receives, Regeneron, regulatory 0

Shots:

  • The approval is based on 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 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

The post Regeneron’s Evkeeza (evinacumab-dgnb) Receives the US FDA’s Approval for Patients with Homozygous Familial Hypercholesterolemia first appeared on PharmaShots.