Shots: The P-IIIb PONENTE study evaluates the safety & efficacy of Fasenra (30mg, SC, q8w) in adult patients with sev. eosinophilic asthma on high-dose ICS + LABA & long-term use […]readmore
Tags : Fasenra
Shots: It is based on P-lllb PONENTE trial assessing Fasenra (benralizumab, 30mg) in adult patients with severe Asthma on high-dose ICS + LABA and long-term use of OCS therapy with […]readmore
Shots: The P-III OSTRO study involves assessing of Fasenra (30mg, SC, q4w for first three doses and q8w thereafter) vs PBO in 413 patients with nasal polyposis who were still […]readmore
Shots: The US FDA has granted orphan drug designation to Fasenra (benralizumab) for the treatment of eosinophilic esophagitis (EoE) following OD designation for EGPA in Nov’2018 and for hypereosinophilic syndrome […]readmore
Shots: The positive CHMP opinion of Forxiga (dapagliflozin) follows P-III DECLARE-TIMI 58 study evaluating the CV outcomes in 17,000+ patients with T2D across 33 countries resulted in reduction in hospitalization […]readmore
Shots: The P-II (NCT02130882) study involves assessing of Fasenra (benralizumab,30mg, q4w) vs PBO in 20 patients with HES who had at least 1,000 eosinophils/µL of blood The P-II (NCT02130882) clinical […]readmore
Shots: Kyowa Kirin to receives upfront, regulatory & commercial milestones. AstraZeneca to get global rights to develop & commercialize Fasenra (beralizumab) for all indication across 14 Asian countries including Japan […]readmore
Regulatory
AstraZeneca’s Fasenra Receives Orphan Drug Designation (ODD) For Hypereosinophilic Syndrome
Shots: The FDA’s ODD for Fasenra follows its evaluation in P-II study assessing Fasenra vs PBO @12 weeks in patients with high level of eosinophils in blood and tissues The […]readmore
Shots: The BORA P-III trial involves assessing of Fasenra (benralizumab) enrolling patients in ratio (1:1) who have completed one of the two SIROCCO or CALIMA P-III trials, administering Fasenra 30 […]readmore
Shots: The comparison study led to assessing of Nucala (mepolizumab), Fasenra (benralizumab), Cinqair (reslizumab) in patients aged ≥12 yrs with similar blood eosinophil counts for the treatment of severe eosinophilic […]readmore