AstraZeneca Gets Positive CHMP Opinion For Asthma Candidate
Zacks Investment Research | Nov 12, 2017 09:25PM ET
AstraZeneca, plc (NYSE:AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending marketing approval of its respiratory disease candidate, benralizumab. AstraZeneca is looking to get benralizumab approved as an add-on maintenance treatment for severe eosinophilic asthma in adults.
The candidate is also under review in the United States with a response from the FDA expected this year. Meanwhile, benralizumab is also being evaluated for the treatment of chronic obstructive pulmonary disease (COPD) in late-stage studies.
The CHMP opinion was based on positive data from pivotal studies, SIROCCO and CALIMA, which showed significant reductions in exacerbations and improvements in lung function on treatment with benralizumab. Meanwhile, another phase III study, ZONDA, showed that adding benralizumab to standard of care led to statistically-significant and clinically relevant reduction in daily maintenance oral corticosteroid (OCS) use with two benralizumab dosing regimens compared with placebo.
So far this year, AstraZeneca’s shares have gained 20.4% comparing favorably with the Zacks Investment Research
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