Policy & Regulation
AstraZeneca fails to meet primary endpoint in Galathea phase III Fasenra trial
15 May 2018 -

United Kingdom-based AstraZeneca has failed to meet its primary endpoint in the Galathea phase III trial of its respiratory drug Fasenra (benralizumab), it was reported yesterday.

The study has failed to achieve statistically-significant reduction in exacerbations in patients with chronic obstructive pulmonary disease. The company is continuing the Terranova trial, which is also a second phase III trial of Fasenra. The results from the trial are likely to be revealed by the end of this quarter.

Galathea and Terranova are randomised, double-blinded, 56-week placebo-controlled and multi-centre trials, intended to assess the safety and efficacy of Fasenra as an add-on to dual or triple inhaled therapy compared with placebo in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) with a history of exacerbations across a range of baseline blood eosinophils. The safety and tolerability findings in the Galathea study are in line with the earlier trials conducted with Fasenra.



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