Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

 Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Shots:

  • The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment
  • The therapy is currently being evaluated in ongoing P-III program including PEARL 1 & -2 that assess Ligelizumab vs Xolair (omalizumab) in ~2000 patients across the globe with its anticipated results in H2’21
  • Ligelizumab is a next generation monoclonal anti-IgE Ab, that demonstrated more patients experienced complete resolution of wheals (hives) in a P-IIb dose-finding trial. The company is anticipating the US regulatory submission in 2022

to­ read full press release/ article | Ref: Novartis | Image: PMLive

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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