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FDA Approves Beovu for Diabetic Macular Edema

It’s the second FDA-approved indication for the drug.




EAST HANOVER, NJ — Novartis announced that the U.S. Food and Drug Administration has approved Beovu for the treatment of diabetic macular edema.

The approval represents the second FDA-approved indication for Beovu (brolucizumab-dbll 6 milligrams), which was first approved for the treatment of wet age-related macular degeneration in 2019, according to a press release. Per the approved Beovu prescribing information, following the loading phase of five doses injected six weeks apart, patients should be treated once every eight to 12 weeks.

“The FDA approval of BEOVU in DME marks a significant milestone for US DME patients, many of whom are of working age and struggle with treatment adherence while juggling multiple doctor’s visits every month,” said Jill Hopkins, senior vice president and global development unit head, ophthalmology, Novartis.

Hopkins added: “This FDA approval follows the recent European Commission approval and allows more patients around the world to potentially benefit from this important medicine.”



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