AstraZeneca & Amgen Seek EU Fast-Track For Severe Asthma Drug
Tezepelumab was among four products that the European Medicines Agency most recently considered for review under its accelerated assessment mechanism.
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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.
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.
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.