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
Ref: Novartis | Image: Novartis
Click here to read the full press release
This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com