CIS Bio removes Scintimun from EMEA consideration

French dugmaker CIS bio international SA says it has formally notified the European Medicines Agency (EMEA) of its decision to withdraw its drug Scintimun (besilesomab) from the agency's review process. The product, which was originally submitted for marketing authorization consideration in February 2005, is a radiopharmaceutical agent intended for use in molecular imaging.

Following its review of initial application data, the EMEA's Committee for Medicinal Products for Human Use requested that CIS bio provide additional safety nformation, which the firm says, in its official withdrawal letter, it was unable to produce in the timeframe set out by the regulatory body. The product is currently licensed in the Czech Republic, Hungary and Sweden, where the company intends to continue its supply.