Beovu has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, Novartis announced in a press release.
An investigational product for the treatment of wet age-related macular degeneration, Beovu (brolucizumab 6 mg) demonstrated noninferiority to aflibercept in the phase 3 HAWK and HARRIER clinical trials. Approximately 30% of patients treated with Beovu in the trials gained at least 15 letters of visual acuity at 1 year, the release said.
“Today’s CHMP opinion brings us another step closer to providing wet AMD patients in Europe with a new treatment option,” Nikos Tripodis, worldwide franchise head, Novartis Ophthalmology, said in the release.
The FDA approved Beovu in October. The European Commission is expected to make its final decision in the first quarter of 2020.