UK-based pharmaceutical giant AstraZeneca Inc. (NASDAQ: AZN) has announced the official market launch of its monoclonal antibody Fasenra (benralizumab) in China. The drug is approved as a maintenance therapy for severe eosinophilic asthma (SEA) in adults and adolescents aged 12 and above.
Clinical Trial and Approval
Fasenra received marketing approval in China in August of last year following positive results from the Phase III MIRACLE study. In this trial, benralizumab demonstrated significant efficacy in reducing the annual acute attack rate (AAER) of asthma in SEA patients. Specifically, patients with baseline blood eosinophils ≥ 300/μL treated with 30mg of benralizumab (30mg Q8W, first three doses Q4W) experienced a 74% reduction in AAER within 48 weeks compared to placebo (p<0.0001).
Drug Development History
Originally developed by Japan-based Kirin Pharma, benralizumab was licensed to MedImmune in December 2006 for commercialization in the US, Europe, and other regions. Following AstraZeneca’s acquisition of MedImmune for USD 15.6 billion in April 2007, the company expanded its commercialization rights to include Japan in October 2016. AstraZeneca further solidified its global rights to the drug through another deal with Kirin Pharma in March 2019, securing development and commercialization rights in Asia and globally.-Fineline Info & Tech
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