AZ/Amgen Fail In EU Fast-Track Bid For Tezepelumab
Asthma Drug Marketing Application Will Be Reviewed Under Standard Timelines
European drug reviewers are not convinced that AstraZeneca and Amgen's investigational treatment for severe asthma, tezepelumab, should be fast-tracked through the EU evaluation system once the companies file for approval.
You may also be interested in...
Calliditas Therapeutics' lead product candidate Nefecon will be fast-tracked at the EMA once the marketing application is filed. Takeda and Bayer are hoping for the same success with aribavir and copanlisib respectively.
A number of advanced therapies are likely to be approved in the EU this year.
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.