Novartis Reports the US FDA and EMA Filing Acceptance of Beovu for Patients with Diabetic Macular Edema

October 14, 2021 Auto Bot Beovu, Diabetic Macular Edema, EMA, FDA, Novartis, regulatory 0

Shots:

  • The US FDA has accepted the sBLA and EMA has validated the type-II variation application for Beovu (brolucizumab, 6mg) for the treatment of DME. Additionally, the PMDA has accepted an application for Beovu for the same indication
  • The application is based on P-III KESTREL and KITE studies, which met their 1EPs of non-inferiority in change in BCVA from baseline vs aflibercept @1yrs. and showed potential for fluid resolution in more DME patients with fewer injections. The therapy demonstrated a favorable benefit-risk profile in both clinical studies
  • The company is expecting the regulatory decision from the US and EU in mid-2022

Click here to­ read full press release/ article | Ref: Novartis | Image: Clinical Trials Arena

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