AstraZeneca’s Fasenra Receives NMPA’s Approval to Treat Severe Eosinophilic Asthma
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- The approval was based on a P-III (MIRACLE) study that assessed the safety & efficacy of Fasenra (benralizumab) as maintenance therapy for severe eosinophilic asthma adults (n=695; age≥12). Currently approved in >80 countries globally (incl. US & EU)
- Fasenra (30mg, SC, Q8W) achieved all 1EPs and key 2EPs vs PBO that shows reduced in AAER over 48 wks by 74% (0.49 vs 1.88) & 2EPs changed at 48wks in pre-bronchodilator FEV1 and TASS. Safety and tolerability were consistent with the known safety profile
- Fasenra is being assessed in other indications such as COPD, CRSwNP, EGPA & hypereosinophilic syndrome. Fasenra is an in-license from BioWa (a subsidiary of Kyowa Kirin) and developed by AstraZeneca
Ref: AstraZeneca | Image: AstraZeneca
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
