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Trial results

Mixed news for AstraZeneca’s drug development portfolio

Pharmaceutical company AstraZeneca has released mixed news about the performance in clinical trials of two of its products.

While its injection for severe asthma (benralizumab) fared well, substantially cutting the need for patients with severe asthma to take oral steroids, a study involving its non-insulin diabetes drug Bydureon failed to show an expected benefit in reducing heart risks.

Results from the phase III ZONDA trial of benralizumab, published in the New England Journal of Medicine[1] (online, 22 May 2017) and presented at the American Thoracic Society 2017 International Congress, held in Washington DC from 19 to 24 May 2017, show that patients were more than four times as likely to reduce or discontinue their oral corticosteroids when benralizumab was added to standard of care, compared with placebo. The results show that the median reduction in oral steroid dose was 75% for patients treated with benralizumab versus 25% with placebo.

Benralizumab also reduced overall exacerbation rates by 70% and exacerbations requiring emergency room visits or hospitalisations by 93% in patients with severe, uncontrolled eosinophilic asthma.

Lead author Parameswaran Nair, professor of respiratory medicine at McMaster University in Hamilton, Canada, says: “This is likely due to its unique mechanism of action of inhibiting the receptor for interleukin-5 and potentially depleting blood and airway eosinophils.

However, the phase IIIb/IV EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial, which compared the effect of once-weekly Bydureon (exenatide extended-release) versus placebo, when added to usual type 2 diabetes care, in adults with type-2 diabetes at a wide range of cardiovascular risk, failed to meet its primary endpoint of reducing cardiovascular risk.

The study, which involved more than 14,000 patients from 35 countries, reported that fewer cardiovascular events were observed in the Bydureon arm, but that the reduction in cardiovascular risk did not reach statistical significance.

A full evaluation of the EXSCEL data will be presented at the European Association for the Study of Diabetes annual meeting on 14 September 2017 in Lisbon, Portugal.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202849

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  • Exterior of the AstraZeneca's manufacturing facility at Snackviken, Sweden

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