Novartis: FDA and EMA decisions for Beovu
(CercleFinance.com) - Novartis announced today that the US Food and Drug Administration (FDA) has accepted the company's supplemental biologics license application (sBLA) and the European Medicines Agency (EMA) has validated the type II variation application for Beovu (brolucizumab) 6 mg for the treatment of diabetic macular edema (DME).
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has also accepted an application for Beovu in the treatment of DME.
Regulatory decisions for Beovu in DME are expected in mid-2022 for the US and Europe.
DME is the leading cause of blindness in adults in developed countries, affecting 12% of people with type 1 diabetes, and 28% of those with type 2 diabetes.
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The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has also accepted an application for Beovu in the treatment of DME.
Regulatory decisions for Beovu in DME are expected in mid-2022 for the US and Europe.
DME is the leading cause of blindness in adults in developed countries, affecting 12% of people with type 1 diabetes, and 28% of those with type 2 diabetes.
Copyright (c) 2021 CercleFinance.com. All rights reserved.