Tags : Fasenra

Biotech Regulatory

AstraZeneca Receives the US FDA’s Orphan Drug Designation for its

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 in Feb’2019              The FDA’s OD designation is granted to the new therapies intended for the treatment, diagnosis or prevention of rare diseases or disorders that […]Read More


AstraZeneca and the US NIAID Report Results of Fasenra (benralizumab)

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 study results: @12wks. reduction in absolute blood eosinophil counts >50% (90% vs 30%); @48wks.maintained reduction in eosinophil counts (74%); patients taper off other HES therapies […]Read More


AstraZeneca Signs Development and Commercialization Agreement with Kyowa Hakko Kirin

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 In Mar,2017 AstraZeneca & Kyowa Kirin collaborated to develop & commercialize Fasenra (beralizumab) for severe asthma and chronic obstructive pulmonary disease (COPD) in Asia Fasenra […]Read More


GSK’s Nucala Proves to be Superior than AZ’s Fasenra and

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 asthma Results: Nacula 100mg SC reduces clinically significant exacerbations (34% to 45% vs Fasenra 30mg) and (45% vs Cinqair 3mg/kg) in ≥400 cells/μL based on […]Read More