The European Commission gave a green light to Novartis AG’s eye-disease drug Beovu on Monday, opening a path to reach patients in the bloc’s health-care systems.
The treatment is for a chronic disease that affects the elderly called wet age-related macular degeneration, and it was approved in the U.S. in October. The Swiss drug maker reported $35 million in Beovu sales for the fourth quarter. Novartis is targeting blockbuster status for the drug, which means eventually reaching over $1 billion in annual revenue.
Paul Spittle, head of global marketing for Novartis, told Dow Jones Newswires that he expects European sales of Beovu to begin in the second quarter.
“We expect to quickly enter key markets,” Mr. Spittle said. Following European Commission authorization, Novartis has to negotiate pricing deals for the drug with individual health authorities in each European member states.
The approval is based on the Hawk and Harrier Phase 3 clinical trials. In the studies, Beovu demonstrated non-inferior visual improvements in patients with the eye disease compared with Regeneron Pharmaceuticals’ rival treatment aflibercept, also known as Eylea. The medicine is currently the main treatment for wet AMD in Europe.
All wet AMD drugs require injections into the eye, however Novartis said that Beovu’s less-frequent dosing presented a differentiating factor to rivals.
“From a retina specialist perspective, the feedback has been really positive,” Mr. Spittle said. “We believe we can quickly take market share,” he added.
