AstraZeneca’s Fasenra Receives the CHMP’s Positive Opinion for Treating Eosinophilic Granulomatosis with Polyangiitis
Shots:
- The CHMP has granted positive opinion to the company’s Fasenra (benralizumab) as an addon therapy for treating r/r eosinophilic granulomatosis with polyangiitis (EGPA) in adults
- The opinion was based on P-III (MANDARA) trial assessing the safety & efficacy of Fasenra (single 30mg, SC, Q4W) vs mepolizumab (separate 100mg, SC, Q4W) for treating adults (n=140) with r/r EGPA, in ratio 1:1
- Study demonstrated remission in 60% of them (comparable to mepolizumab) and 41% vs 26% fully stopped oral corticosteroids (OCS), with safety & tolerability that aligned with the previous profiles of the drugs. Data was published in The New England Journal of Medicine
Ref: AstraZeneca | Image: AstraZeneca
Related News: AstraZeneca’s Fasenra Receives the US FDA’s Approval for the Treatment of Eosinophilic Granulomatosis with Polyangiitis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.