Novartis AG said Thursday that the European Union has approved its drug Beovu as a treatment for blindness in people living with diabetic macular edema, or DME.
The approval by the bloc's executive arm, the European Commission, follows successful Phase 3 study data that met a primary endpoint of non-inferiority in change in best-corrected visual acuity from baseline versus aflibercept at year one, the Swiss drug maker said.
The decision means Beovu will be available as a treatment for DME, a leading cause of blindness among adults in developed countries, across the EU and in Iceland, Liechtenstein and Norway, the company said.
The approval is the second granted to Beovu, which the EC in 2020 approved as a treatment for wet age-related macular degeneration, Novartis said.
Beovu remains under review for approval in the U.S. and Japan, Novartis said.
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