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AstraZeneca & Amgen Seek EU Fast-Track For Severe Asthma Drug

Executive Summary

Tezepelumab was among four products that the European Medicines Agency most recently considered for review under its accelerated assessment mechanism.

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EU Accelerated Assessment Tracker

Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.

EU Accelerated Assessment Tracker

One out of seven requests for the accelerated assessment of planned EU marketing authorization applications is known to have been granted this year to date.

Amgen/AstraZeneca’s Tezepelumab Cuts Asthma Exacerbations By 56%

Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics. 

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