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Novartis Reports P-III (APPLY-PNH) Trial Results of Iptacopan for Paroxysmal Nocturnal Hemoglobinuria

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Novartis Reports P-III (APPLY-PNH) Trial Results of Iptacopan for Paroxysmal Nocturnal Hemoglobinuria

Novartis Reports P-III (APPLY-PNH) Trial Results of Iptacopan for Paroxysmal Nocturnal Hemoglobinuria

Shots:

  • The P-III (APPLY-PNH) trial evaluating iptacopan monothx. (200mg, BID) vs eculizumab or ravulizumab in a ratio (8:5) in 97 adult patients with PNH with residual anemia
  • The trial met its two 1EPs & showed iptacopan was superior to anti-C5 therapies with Hb level increases of ≥2g/dL from baseline without needing blood transfusions @24wks. while ≥12g/dL @24wks., was well tolerated with a favorable safety profile consistent with prior reported data
  • The therapy is being evaluated in P-III (APPOINT-PNH) trial for PNH with expected results in the coming months & is being studied in P-III (APPEAR-C3G) trial for CMKDs C3 glomerulopathy, (APPLAUSE-IgAN) for IgA nephropathy and (APPELHUS) for aHUS along with additional indication in P-II study

Ref: Novartis | Image: Novartis

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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