Shots: The P-III SOURCE study involves assessing Tezepelumab (210mg, q4w) vs PBO in 150 adult patients as add-on therapy with patients maintained on their currently prescribed ICS + LABA, with/ out other asthma controller therapy for 48wks. The trial did not meet its 1EPs i.e., reduction in the daily OCS dose, without loss of asthma […]Read More
Tags : Tezepelumab
Shots: The P-III NAVIGATOR study involves assessing Tezepelumab + SOC vs PBO + SOC in adults (18–80yrs.) & adolescents (12–17yrs.) with severe, uncontrolled asthma, who were receiving treatment with medium/high dose ICS + at least 1 additional controller medication with or without OCS Trial met its 1EPs i.e. reduction in AAER @52wks. in the overall […]Read More
AstraZeneca’s Tezepelumab (thymic stromal lymphopoietin antagonist) Receives FDA BT Designation
Shots: The designation is based on P-IIb PATHWAY assessing (tezepelumab vs PBO) in patients with asthma exacerbations, uncontrolled asthma receiving inhaled corticosteroids/LA- β2-agonists w/o oral corticosteroids and additional asthma controllers P-IIb PATHWAY involves administering of (70/210mg q4w or 280mg q2w) which showed reduction in annual asthma exacerbation rate reductions of 62%, 71% and 66% vs […]Read More