EMEA accepts MAA for La Jolla's Riquent

La Jolla Pharmaceutical says that its Marketing Authorization Application for Riquent (abetimus sodium), its drug candidate for lupus renal disease, has been accepted for review by the European Medicines Agency (EMEA) for potential approval in the European Union.

The EMEA's review of the application, which was filed on March 31, will follow the centralized procedure. If approved, Riquent will receive marketing authorization in all 25 EU member states, as well as Norway, Iceland and Liechtenstein. Riquent has already received Orphan Medicinal product designation in Europe, which will provide 10 years of market exclusivity from the date of authorization and it also has US Orphan Drug status and fast-track designation.

In October 2004, following a review of Riquent's New Drug Application, the US Food and Drug Administration informed La Jolla that the agent was "approvable" pending the successful completion of a clinical benefit trial, which is currently underway via a Special Protocol Assessment.