Novartis's Beovu Gets EU Approval as Blindness Treatment
31 Marzo 2022 - 11:59PM
Noticias Dow Jones
By Joshua Kirby
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.
Write to Joshua Kirby at joshua.kirby@wsj.com;
@joshualeokirby
(END) Dow Jones Newswires
March 31, 2022 01:44 ET (05:44 GMT)
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