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).
“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 a company news release. “At Novartis, we remain committed to reimagining treatments for patients suffering from wet AMD, a leading cause of blindness worldwide.”
The positive CHMP opinion is based on findings from the phase 3, global, head-to-head HAWK and HARRIER clinical trials, in which Beovu demonstrated noninferiority versus aflibercept in mean change in best-corrected visual acuity from baseline to year one.1 In both trials, approximately 30% of patients treated with Beovu gained at least 15 letters at year one.1
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 1 (30% fewer patients in HAWK and 41% fewer patients in HARRIER).1 Significant reductions in central subfield thickness were also seen with Beovu.1
Additionally, over half (56% in HAWK and 51% in HARRIER) of patients treated with Beovu 6mg maintained a 3-month dosing interval immediately after the loading phase through year one.1 Beovu patients who started on 3-month dosing intervals after the loading phase had an 85% (HAWK) and 82% (HARRIER) probability of remaining on this interval through year one.1
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 pain1.
In October 2019, Novartis received the first, and so far the only, approval for Beovu from the FDA 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 3 months.
- Dugel P, et al. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. https://www.ncbi.nlm.nih.gov/pubmed/30986442. Accessed December 2019.