The European Medicines Agency has been formally notified by Pfizer Limited of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorised medicine, Macugen (pegaptanib sodium), 0.3 mg solution for injection.
On 14 June 2010, Pfizer Limited submitted an application to extend the marketing authorisation for Macugen to include the treatment of visual impairment due to diabetic macular oedema in the indication. At the time of withdrawal, the application was under review by the Agency’s Committee for Medicinal Products for Human Use (CHMP).
Macugen was first authorised in the European Union on 31 January 2006. It is currently authorised for treatment of neovascular (wet) age-related macular degeneration.
In its official letter, the company stated that its decision to withdraw the application was based on the CHMP’s view that the data provided so far does not allow the Committee to conclude on a positive benefit-risk balance in the applied for indication.
Macugen continues to be authorised in the currently approved indication.