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

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

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

Shots:

  • The approval is based on P-III head-to-head PEGASUS study assessing Empaveli 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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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