- AstraZeneca Plc AZN has announced results from a new integrated analysis, including data from the MELTEMI Phase 3 open-label extension trial, evaluating Fasenra (benralizumab) in adult patients with severe asthma.
- Results were presented today at the American Thoracic Society 2021 International Conference.
- Data showed Fasenra was well-tolerated for up to five years, with a long-term safety profile consistent with previous Phase 3 trials.
- During the extension trials, adverse events and serious adverse events did not increase from rates comparable to placebo observed in Phase 3 trials.
- In secondary endpoints, Fasenra sustained the reduction in asthma exacerbation rates observed during predecessor Phase 3 trials, with annualized asthma exacerbation rates (AAER) remaining consistently low over the five-year treatment period.
- AAER decreased from 3.1 exacerbation/year pre-treatment to 0.5 in the predecessor studies with a further reduction to 0.2 by year four of the open-label trial.
- 59% of patients experienced zero exacerbations during the four years of the open-label period, and at least 75% of patients each year experienced zero exacerbations.
- In the final year of the trial, 87% of patients experienced zero exacerbations.
- Price Action: AZN shares are up 0.26% at $56.14 during the market session on the last check Wednesday.
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