Novartis’ Beovu scores CHMP recommendation after proving non-inferior to Eylea in wet age-related macular degeneration

pharmafile | December 13, 2019 | News story | Medical Communications, Sales and Marketing |  Beovu, EMA, Novartis, pharma 

Novartis’ single-chain antibody fragment Beovu has secured recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of wet age-related macular degeneration (AMD), is has emerged.

The ruling was reached on the back of Phase 3 data in which Beovu proved itself to be non-inferior compared to Regeneron’s Eylea in terms of average best-corrected visual acuity from baseline throughout one year of treatment. As the data shows, Beovu allowed around 30% of patients to gain 15 letters after the first year.

Additionally, 30% and 41% fewer Beovu patients showed intra-retinal and/or sub-retinal fluid after 16 weeks of treatment across two clinical trials.

If previous indications are anything to go by, this strengthens the chances of approval for Beovu within the EU. The drug has secured one indication so far, with the FDA for the treatment of wet AMD, in October earlier this eyar.

“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.”

Matt Fellows