Novartis’ Iptacopan (LNP023) Receives the US FDA’s Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3G

 Novartis’ Iptacopan (LNP023) Receives the US FDA’s Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3G

Shots:

  • The US FDA has granted BTD in paroxysmal nocturnal hemoglobinuria and RPDD in C3 glomerulopathy
  • The BTD is based on results from two ongoing P-II studies, where iptacopan showed benefits both in patients who remained anemic and dependent on transfusions despite SOC anti-complement treatment as well as monothx. in anti-C5 naïve PNH patients
  • Iptacopan is a first-in-class, orally administered, potent and highly selective factor B inhibitor of the alternative complement pathway with its first FDA filing anticipated in 2023

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Financial Times

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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