Novartis: FDA, EMA filing acceptances of Beovu for diabetic macular edema

 

• Regulatory decisions for Beovu (brolucizumab) in diabetic macular edema (DME) are expected in mid-2022 in the US and Europe

• DME is the leading cause of blindness in adults in developed countries; unmet needs in DME include improving fluid resolution and addressing the burden of frequent treatment schedules^1-3

• The regulatory applications are based on year one data from the Phase III KESTREL and KITE trials investigating Beovu 6 mg versus aflibercept 2 mg in DME patients⁴

• In KESTREL and KITE, Beovu was non-inferior to aflibercept in change in BCVA from baseline and showed potential for fluid resolution in more DME patients with fewer injections⁴

• Beovu demonstrated a favorable benefit-risk profile in KESTREL and KITE⁴

• The Japanese PMDA also accepted an application for Beovu in DME

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