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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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