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

  Ref: GlobeNewswire | Image: Contract Pharma