The US Food and Drug Administration (FDA) has approved Beovu (brolucizumab; Novartis) 6 mg for the treatment of diabetic macular edema (DME), according to a press release. This is the second FDA-approved indication for brolucizumab, which was approved for the treatment of wet age-related macular degeneration in 2019.
“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, SVP and Global Development Unit Head, Ophthalmology, Novartis in the press release. “KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting BEOVU may offer fewer injections from the start of treatment through year one. We look forward to offering a new treatment option to help address the unmet needs of patients with DME. 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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