AstraZeneca, plc (AZN - Free Report) 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 industry’s growth of 14.5%.
AstraZeneca’s respiratory products on the market include Symbicort, Pulmicort Tudorza, Duaklir and others. Sales of its respiratory portfolio have declined 5% so far this year.
Other than benralizumab, promising respiratory treatments in the pipeline include tralokinumab,in phase III studies for severe asthma, and PT010, also in phase III studies for the treatment of COPD. It remains to be seen if these candidates can improve AstraZeneca’s respiratory sales upon approval.
AstraZeneca carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked stocks in the industry are Johnson & Johnson (JNJ - Free Report) , PDL BioPharma, Inc. (PDLI - Free Report) and Ligand Pharmaceuticals Incorporated (LGND - Free Report) , all with a Zacks Rank #2 (Buy).
Shares of J&J are up 21.1 % while earnings estimates for 2018 have gone up by 1.2% over the past 30 days.
Shares of PDL BioPharma have increased 43.4% this year so far while earnings estimates for 2018 have increased 3.2% in the past 30 days.
Shares of Ligand Pharmaceuticals have risen 37.6% this year so far while earnings estimates for 2018 have increased 0.5% in the past 60 days.
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