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AstraZeneca's (AZN) Asthma Drug Benralizumab Approved by FDA

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AstraZeneca, plc (AZN - Free Report) announced that the FDA has granted approval to its asthma disease candidate, benralizumab. Benralizumab, approved as an add-on maintenance treatment for severe eosinophilic asthma in patients aged 12 years and older, will be marketed by the trade name of Fasenra.

Shares of this London, United Kingdom based pharma giant were up more than 1% on Tuesday. So far this year, AstraZeneca’s shares have gained 21.7%, comparing favorably with the industry’s growth of 14.4%.

Fasenra will be given as a fixed-dose subcutaneous injection via a prefilled syringe, once in every eight weeks, making it the first respiratory biologic medicine to be approved with the convenient 8-week maintenance dosing schedule. GlaxoSmithKline’s (GSK - Free Report) Nucala (subcutaneous administration) and Teva Pharmaceutical Industries' (TEVA - Free Report) Cinqair (intravenous infusion) are presently marketed for the same indication but administered once every four weeks

The FDA approval of Fasenra 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.

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 the potential to reduce oral steroid use in such patients.

Fasenra is under regulatory review in the EU, Japan and many other countries. Earlier this week, AstraZeneca said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval of benralizumab.

Asthma is a chronic inflammatory disease of breathlessness and has a significant unmet medical need. This is because it 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 - Free Report) .

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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