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Tezepelumab Deemed Breakthrough But Can Phase III Reproduce Data?

 
• By Sten Stovall

Biologic's breakthrough designation is based on Phase IIb PATHWAY data that showed tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma.

Lungs
tezepelumab targets 'master switch' thought to control inflammatory pathways in patients with severe asthma • Source: Shutterstock

The FDA has granted AstraZeneca PLC's first-in-class tezepelumab breakthrough designation in patients with severe asthma, potentially accelerating its development and review. To successfully do that, though, the drug will need to reproduce the impressive clinical data supporting the decision in Phase III studies.

The breakthrough designation is based on Phase IIb PATHWAY data which showed tezepelumab significantly reduced asthma exacerbations compared with placebo in severe asthma. The decision by the US drug regulator...

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