Apellis’ Empaveli (pegcetacoplan) Receives the US FDA’s Approval for Paroxysmal Nocturnal Hemoglobinuria

May 17, 2021 Auto Bot approval, Empaveli, FDA, regulatory, Soliris, Ultomiris 0

Shots:

  • The approval is based on P-III head-to-head PEGASUS study assessing Empavel vs Soliris (eculizumab) in 80 adults with PNH. Participants should be Soliris stable for at least 3mos. with a Hgb level of <10.5 g/dL at the screening visit
  • Results: The study met its 1EPs demonstrating superiority to Soliris for the change from baseline in hemoglobin level @16wks. with an adjusted mean increase of 3.84 g/dL of Hgb. Additionally, therapy met non-inferiority on the endpoint of transfusion avoidance (85% vs 15%)
  • Empaveli is the first and only targeted C3 therapy, approved in the US for use in adults with PNH who are treatment naïve and patients switching from the C5 inhibitors Soliris & Ultomiris

Click here to­ read full press release/ article | Ref: GlobeNewswire | Image: Contract Pharma

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