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Amgen, AstraZeneca asthma drug secures US FDA breakthrough tag

Amgen Inc. and AstraZeneca PLC said the U.S. Food and Drug Administration granted breakthrough therapy designation to tezepelumab in patients with a type of asthma.

The designation is for tezepelumab in patients with severe asthma without an eosinophilic phenotype. Eosinophils are a subtype of white blood cells that are known to cause inflammation contributing to asthma.

The regulator's decision is based on results of a phase 2b study, called Pathway, in which the drug significantly reduced the rate of serious asthma attacks compared to placebo.

Breakthrough status allows for an expedited review process for drugs that treat serious or life-threatening diseases.

U.K.'s AstraZeneca and Thousand Oaks, Calif.-based Amgen are collaborating to develop tezepelumab. The medicine is designed to block a type of protein that drives inflammation in asthma.

The companies also studying tezepelumab in a phase 3 trial program called Pathfinder.

Asthma affects 334 million people globally, up to 10% of whom have severe asthma.