AstraZeneca's Asthma Drug Fasenra Fails In COPD Study

On May 11, AstraZeneca, plc AZN announced its 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).  Shares of the company did not seem to react to the news, gaining slightly during that day's trading session.

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.

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