Novartis Reports the US FDA and EMA Filing Acceptance of Beovu for Patients with Diabetic Macular Edema
Novartis Presents Two-Year Data of Cosentyx (secukinumab) in P-III JUNIPERA Study for JPsA and ERA at ACR 2021
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