Novartis gets breakthrough designation for Xolair successor, setting up spotlight for PhIII readout later this year
With its Roche-partnered Xolair no longer under patent protection, Novartis and CEO Vas Narasimhan are looking for the next drug up to step into the sales void. Now, Narasimhan’s targeted successor is getting some love from the FDA, and it could spell a filing down the road.
The FDA granted breakthrough therapy designation to the company’s ligelizumab compound for the treatment of chronic spontaneous urticaria in patients who respond poorly to antihistamines, Novartis said Thursday.
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