Novartis receives positive CHMP opinion for Beovu (brolucizumab) for the treatment of wet AMD

  • Patients & Caregivers
  • Healthcare Professionals
  • Society & ESG

  • In two head-to-head clinical trials, patients on Beovu achieved vision gains that were non-inferior to aflibercept at year one1
  • In a pre-specified secondary endpoint, fewer patients had intra-retinal fluid and/or sub-retinal fluid at week 16 and year one with Beovu1
  • In a key pre-specified secondary endpoint, over half of Beovu 6mg patients (56% in HAWK and 51% in HARRIER) were maintained on three-month dosing intervals immediately after the loading phase through year one1
  • Frequent injections are a common reason patients drop off treatment for wet AMD, a leading cause of blindness that affects more than 20M people worldwide2-4

Basel, December 13, 2019 - Novartis today 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," said Nikos Tripodis, Worldwide Franchise Head, Novartis Ophthalmology. "At Novartis, we remain committed to reimagining treatments for patients suffering from wet AMD, a leading cause of blindness worldwide."

Wet AMD is caused by uncontrolled VEGF, a protein that promotes abnormal blood vessel formation underneath the macula, the area of the retina responsible for sharp, central vision5,6. These blood vessels are fragile and leak fluid, disrupting the normal retinal architecture and ultimately causing damage to the macula5,6. By inhibiting VEGF, Beovu is designed to suppress the growth of abnormal blood vessels and the potential for fluid leakage into the retina1.

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 one1. In both trials, approximately 30% of patients treated with Beovu gained at least 15 letters at year one1.*

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)1. Significant reductions in central subfield thickness were also seen with Beovu1.

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 one1. 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 one1.

Beovu exhibited an overall safety profile comparable to aflibercept. The most common adverse events (