EU Commission approves Bayer's Eylea for wet AMD and Abbott's Humira for pediatric Crohn's

There was good news yesterday for Germany’s Bayer (BAYN: DE) and US health care major Abbott Laboratories (NYSE: ABT), when the European Commission announced final approval for the former’s ophthalmic agent and expanded use for Abbott’s blockbuster drug Humira (adalimumab).

For Bayer HealthCare, the Commission cleared the firms VEGF Trap-Eye product Eylea (aflibercept solution for injection) for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2mg.

Treatment with Eylea, under development with the USA’s Regeneron Pharmaceuticals (Nasdaq: REGN) and already approved by the Food and Drug Administration for wet AMD and macular oedema following central retinal vein occlusion, is initiated with one injection per month for three consecutive doses, followed by one injection every two months. There is no requirement for monitoring between injections. After the first 12 months of treatment with Eylea, the treatment interval may be extended based on visual and anatomic outcomes. In this case the schedule for monitoring should be determined by the treating physician and may be more frequent than the schedule of injections.