A Phase III registration study evaluating subcutaneously administered reslizumab (110 mg) in a pre-filled syringe did not meet its primary endpoint.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced that a Phase III registration study evaluating subcutaneously administered reslizumab (110 mg) in a pre-filled syringe did not meet its primary endpoint of significantly reducing the frequency of clinical asthma exacerbations in patients with uncontrolled asthma and elevated blood eosinophils. A Phase III claim-support study evaluating subcutaneously administered reslizumab in patients with oral corticosteroid-dependent asthma did not meet its primary endpoint of reduction in daily OCS dose.
Although the asthma market is very large, this drug was targeting a niche market in the illness. The drug, which has received US Food and Drug Administration (FDA) approval in an injectable form, came to Teva through the acquisition of Cephalon in 2011.
Teva SVP Specialty Clinical Development and Medical Affairs Tushar Shah said, “We are disappointed that these trials of the reslizumab formulation administered subcutaneously at a fixed-dose of 110 mg did not meet their primary endpoints. However, these results reinforce the role of eosinophils in severe asthma disease biology and the importance of defining the right blood eosinophil cutoff point for patient selection. We continue to see the positive impact of the intravenous formulation as a clinically effective 3mg/kg weight-based dosing option in patients with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care therapy."
Published by Globes [online], Israel business news - www.globes-online.com - on January 22, 2018
© Copyright of Globes Publisher Itonut (1983) Ltd. 2018
Teva photo: Reuters