Posted by Michael Wonder on 13 Dec 2019
Novartis receives positive CHMP opinion for Beovu (brolucizumab) for the treatment of wet AMD
13 December 2019 - In two head-to-head clinical trials, patients on Beovu achieved vision gains that were non-inferior to aflibercept at year one.
Novartis today announced that the CHMP of the EMA has adopted a positive opinion for Beovu (brolucizumab 6 mg), also known as RTH258, an investigational product for the treatment of wet age-related macular degeneration (AMD).
The positive CHMP opinion is based on findings from the Phase III, global, head-to-head HAWK and HARRIER clinical trials, in which Beovu demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity from baseline to year one. In both trials, approximately 30% of patients treated with Beovu gained at least 15 letters at year one.
