Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

August 13, 2020 Auto Bot Acceptance, BLA, FDA, patients, Priority Review, Regeneron, regulatory, reports, Treatment 0

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)

Click here to­ read full press release/ article | Ref: Regeneron  | Image: CNN