Harsh blow for Biogen as psoriasis drug Amevive stumbles in Europe

Following a negative review from the European Union's Committee forProprietary Medicinal Products, Biogen has withdrawn its application for approval of psoriasis drug Amevive (alefacept). The CPMP has asked for a head-to-head trial of Amevive versus approved therapies - such as cyclosporine, methotrexate or oral retinoids - before it will recommend Biogen's drug for approval by the European Medicines Evaluation Agency.

In addition, the CPMP has asked for more data on high-need patients (ie those who failed or are not eligible for existing therapies). In a statement, Biogen struck a pessimistic note by saying that "developing the data and re-filing the application to gain approval could take several years."

The CPMP's decision has come as a real surprise, given that the US Food and Drug Administration has already given the green light to Amevive (Marketletter February 10), making it the first biologic drug to be registered for the treatment of psoriasis. Some analysts have been predicting blockbuster sales for Amevive, a target which will be hard to meet without the contribution from the EU market. Other negative factors include the impact of the CPMP's decision on the drug's US take-up and likely near-term competition in the psoriasis sector from Amgen's Enbrel (etanercept) and Johnson & Johnson's Remicade (infliximab), both of which are already approved for other indications, and Genentech/Xoma's Raptiva (efalizumab).