FDA approves Eylea for wet AMD

FDA approved an NDA from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) for Eylea aflibercept to treat wet age-related macular degeneration (AMD). The company said it plans to make Eylea available "within the next few days." The recommended dose for Eylea is 2 mg administered monthly for the first three months, followed by 2 mg once every two months. Regeneron said Eylea will be priced at $1,850 per dose, with an annual cost of about $16,000, assuming seven doses per year plus injection costs and office visit costs. Eylea will compete with once-monthly Lucentis ranibizumab from Genentech Inc., a unit of Roche (SIX:ROG; OTCQX:RHHBY). While Regeneron said Lucentis costs $29,000 per year, Genentech said in a statement that the average annual cost of Lucentis in the U.S. typically ranges from $9,750 to $15,600. Genentech added that the range is based on an estimate that in the first year of treatment, the average patient receives eight injections followed by about five injections in the second year. Lucentis has not been studied at eight-week dosing intervals, according to the company (see BioCentury, June 27). ...