Shots:
- The submission is based on PATHFINDER clinical program including P-III NAVIGATOR that involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe and uncontrolled asthma
- The study demonstrated 56% reduction in AAER @52wks. in the overall population. The study also met 1EPs in the subgroup of patients i.e. 41% reduction in low levels of eosinophils <300 cells/microliter, improvements in lung function measurements, asthma control & health related QoL
- Tezepelumab is the only biologic to reduce AAER consistently in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across P-II & P-III studies
Click here to read full press release/ article | Ref: PRNewswire | Image: Amgen
The post AstraZeneca and Amgen Submit BLA to US FDA for Tezepelumab to Treat Severe Asthma first appeared on PharmaShots.
