Applications for Beovu for DME treatment accepted in US, Europe, Japan
Applications for Beovu to treat diabetic macular edema have been accepted in the United States, Europe and Japan, according to a press release from Novartis.
The FDA has accepted a supplemental biologics application for Beovu (brolucizumab), the European Medicines Agency has validated a type II variation application for Beovu, and the Japanese Pharmaceuticals and Medical Devices Agency has accepted an application for Beovu, the release said.
“If approved, Beovu has the potential to provide better fluid resolution and fewer injections during the loading phase and throughout maintenance treatment,” Jill Hopkins, senior vice president and global development unit head, ophthalmology, at Novartis Pharmaceuticals, said in the release.
The applications are based on 1-year data from the phase 3 KESTREL and KITE studies, in which Beovu met its primary endpoint of noninferiority in change from baseline in best corrected visual acuity vs. aflibercept.
Beovu was previously approved for the treatment of wet age-related macular degeneration in the U.S. in 2019 and Europe in 2020. Decisions for the new DME indication are expected in mid-2022 in the U.S. and Europe.