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AstraZeneca’s (AZN) Asthma Drug Fasenra Fails in COPD Study


AstraZeneca, plc’s AZN new asthma drug, Fasenra (benralizumab) did not meet the primary endpoint in a late-stage study evaluating the respiratory biologic medicine for an expanded indication – chronic obstructive pulmonary disease (COPD).

Fasenra was approved in the EU in January and in the United States in November last year as an add-on maintenance treatment in patients with severe eosinophilic asthma. Fasenra is 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 in the United States and the EU with the convenient 8-week maintenance dosing schedule. 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.

Coming back to the latest news, the phase III study, GALATHEA, evaluated the safety and efficacy of Fasenra in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Top-line results from the study showed that treatment with Fasenra, as an add-on to dual or triple inhaled therapy in COPD patients with a history of exacerbations across a range of baseline blood eosinophils, did not result in a statistically-significant reduction of exacerbations compared to placebo.

Full data from the pivotal GALATHEA study is expected to be presented at a future medical meeting. Another pivotal study, TERRANOVA, is also evaluating Fasenra for a similar indication. AstraZeneca will determine the next steps for Fasenra in COPD after it gets results from the TERRANOVA study and full data from the GALATHEA study.

AstraZeneca’s shares have risen 4.9% so far this year against the industry’s decline of 3.4%.

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

A better-ranked large-cap pharma stock is Eli Lilly & Company LLY with a Zacks Rank #2 (Buy). The company’s earnings estimates increased by 4.5% for 2018 and 2.8% for 2019 over the past 30 days.

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