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Amgen: SOURCE Phase 3 Trial For Tezepelumab Fails To Meet Primary Endpoint

Amgen (AMGN) and AstraZeneca announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid dose, without loss of asthma control, with tezepelumab compared to placebo. The safety profile of tezepelumab in the trial was consistent with previous trials. In September 2018, the US FDA granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

"The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021," said David Reese, executive vice president of Research and Development at Amgen.

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