CHMP recommends approval of Beovu in age-related macular degeneration.- Novartis

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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.

In pre-specified secondary endpoints, fewer patients treated with Beovu 6mg versus aflibercept had intra-retinal and/or sub-retinal fluid at week 16 (35% fewer patients in both HAWK and HARRIER) and at year one (30% fewer patients in HAWK and 41% fewer patients in HARRIER). Significant reductions in central subfield thickness were also seen with Beovu. Additionally, over half (56% in HAWK and 51% in HARRIER) of patients treated with Beovu 6mg maintained a three-month dosing interval immediately after the loading phase through year one. Beovu patients who started on three-month dosing intervals after the loading phase had an 85% (HAWK) and 82% (HARRIER) probability of remaining on this interval through year one.

Beovu exhibited an overall safety profile comparable to aflibercept. The most common adverse events (?5% of patients) with Beovu were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain.

Comment: In October 2019, Novartis received the first, and so far the only, approval for Beovu from the U.S. Food and Drug Administration in the treatment of wet AMD. The European Commission will consider the CHMP opinion as it makes its final decision on the marketing authorization for Beovu. The decision is expected within three months.