LA JOLLA WITHDRAWS EUROPEAN APPLICATION FOR RENAL DISEASE DRUG

La Jolla Pharmaceutical has requested the withdrawal of its marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Riquent (abetimus sodium), its drug candidate for lupus renal disease.

In a preliminary assessment of the MAA, the EMEA reviewers indicated that additional clinical data would be needed prior to potential approval. Based on its review of the assessment, the company believes that the ongoing clinical studies of Riquent should provide the necessary data; however, the data will not be available within the time frame that the EMEA regulations allow for the review of the current Riquent application. Therefore, the company has decided to withdraw the current application and plans to resubmit the MAA after the completion of the ongoing clinical trials.

Riquent is the first drug candidate specifically developed for the treatment of lupus renal disease, a leading cause of sickness and death in lupus patients. The drug candidate has already been evaluated in 13 clinical trials over a 10-year time span that evaluated more than 800 patients and subjects. Riquent's only known biological activity is the reduction of antibodies to double-stranded DNA that is associated with the progression of lupus renal disease and renal flares.