AstraZeneca’s Forxiga and Fasenra (Prefilled Syringe and Pen) Receive EU CHMP’s Positive Opinion for CV Outcomes in T2D and Asthma

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 for HF or CV death
• The positive CHMP opinion of Fasenra (prefilled syringe and auto-injector pen) follows P-III GREGALE and GRECO & P-I AMES study evaluating the prefilled syringe & auto-injector device in patients with severe, uncontrolled asthma
• Forxiga is a SGLT2 inhibitor, indicated as both monothx. & combination therapy for impoving glycaemic control as an adjunct to diet and exercise in adults with T2D and is under regulatory review in the US, China & Japan. Fasenra (benralizumab) is a mAb targeting IL-5 receptor alpha on eosinophils with its anticipated FDA’s approval in H2’19

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