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

  Ref: Novartis | Image: Novartis