Regeneron Pharmaceuticals ($REGN) has passed a key test at an FDA advisory committee meeting on its experimental eye drug. The expert panel voted unanimously that the treatment, called VEGF Trap-Eye, should be approved to treat a neurovascular form of age-related macular degeneration.
The panel recommended approval of the drug--which the company plans to sell under the name Eylea--with a dosing schedule of 2 milligrams every 8 weeks after three initial doses every four weeks, according to Regeneron. The ability to provide the drug in more convenient doses is expected to be a key factor in the drug's success on the market, where it would face competition from Roche's once-monthly blockbuster eye drug Lucentis if approved. Both drugs are injected into the eye.
The FDA, which issued a staff review of the experimental drug earlier this week without noting any serious safety concerns, is expected to decide whether to approve the treatment for wet-AMD by Aug. 20. While the FDA will make up its own mind about VEGF Trap-Eye's ultimate fate on the U.S. market, today's panel vote only served to heighten analysts' confidence in the drug's swift approval by the agency.
The FDA experts did flag their concern that this new drug will add to the cost of treatment. And Regeneron Chief Executive Leonard Schleifer declined a chance to reassure the panel on that point, saying only that the company was sensitive to the issue.
Tarrytown, NY-based Regeneron's stock was temporarily halted from trading during Friday's advisory committee meeting on its promising drug, whose generic name is aflibercept ophthalmic solution. The treatment is also under review in Europe, where Bayer, Regeneron's partner for development and marketing of the drug outside the U.S., recently filed for approval.