AstraZeneca: asthma drug gets FDA's 'breakthrough' status
(CercleFinance.com) - AstraZeneca and its US partner Amgen said that the US Food and Drug Administration has granted breakthrough therapy designation for tezepelumab in patients with severe asthma.
The FDA's decision applies to patients without an eosinophilic phenotype, who receive inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.
As a reminder, a breakthrough therapy designation is designed to accelerate the regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results.
A phase IIb trial showed that tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The FDA's decision applies to patients without an eosinophilic phenotype, who receive inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.
As a reminder, a breakthrough therapy designation is designed to accelerate the regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results.
A phase IIb trial showed that tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma.
Copyright (c) 2018 CercleFinance.com. All rights reserved.