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AstraZeneca’s Asthma Drug Benralizumab Gets Approval in EU

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AstraZeneca, plc AZN announced that the European Commission (“EC”) has granted approval to its asthma disease candidate, benralizumab. It is approved as an add-on maintenance treatment for severe eosinophilic asthma in adult patients. It will be marketed by the trade name of Fasenra.

With this approval, Fasenra is the first respiratory biologic drug to have an 8-week maintenance dosing schedule. The drug will be available in a fixed-dose subcutaneous injection via a prefilled syringe.

We remind investors that Fasenra received approval in the same indication in the United States in November last year. It is also under review in Japan

AstraZeneca’s shares have gained 25.1% in the past year, comparing favorably with the industry’s growth of 18.4% in that period.


The EC approved Fasenra based on data from the WINDWARD program, which included three phase III studies – SIROCCO, CALIMA and ZONDA.

Data from SIROCCO and CALIMA showed that Fasenra achieved significant reductions in exacerbations and improvements in lung function. Meanwhile, data from ZONDA study showed that Fasenra alone or in combination with standard of care (glucocorticoid) led to statistically-significant and clinically relevant reduction in daily maintenance oral corticosteroid (“OCS”) compared with placebo.

Severe asthma patients whose disease is driven by inflammation of eosinophils, a type of white blood cell, have until now had only limited treatment options, mostly oral steroids. Fasenra, which distinctively targets and rapidly depletes eosinophils, has shown potential to reduce oral steroid use in such patients.

GlaxoSmithKline’s GSK Nucala (subcutaneous administration) and Teva Pharmaceutical Industries' TEVA Cinqair (intravenous infusion) are presently marketed for the same indication but administered once every four weeks.

Asthma is a chronic inflammatory disease of breathlessness and has a significant unmet medical need. This affects 315 million individuals worldwide and up to 10% of patients who have severe asthma, which can become uncontrolled despite receiving high doses of standard of care medicines and require the use of chronic OCS.

Benralizumab is also being evaluated for the treatment of chronic obstructive pulmonary disease ("COPD") in late-stage studies. Other severe asthma candidates in AstraZeneca’s portfolio are tralokinumab and tezepelumab — in partnership with Amgen, Inc. AMGN.

AstraZeneca’s respiratory portfolio accounted for 23% of total product sales in the first nine months of 2017. The segment saw a decline in sales in the period due to competition and other market conditions. However, addition of another drug in the portfolio will certainly boost performance.

AstraZeneca carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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