Shots:

• The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg- IV- q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline
• The expected PDUFA date for the therapy as Feb 11- 2021. The US FDA has granted BT designation to the therapy for the treatment of hypercholesterolemia in patients with HoFH in 2017
• Evinacumab is an investigational mAb that binds to and blocks the function of ANGPTL3 and is currently being studied in patients with HoFH (ongoing P-III extension trial)- refractory hypercholesterolemia (P-II) and severe hypertriglyceridemia (P-II)

 Ref: Regeneron  | Image: CNN