In a preliminary assessment of the application, the EMEA reviewers indicated that additional clinical data would be needed prior to potential approval.
The company has said that based on its review of the assessment it believes that the ongoing clinical studies of Riquent should provide the necessary data, however the data will not be available within the timeframe that the EMEA has allowed for the application. La Jolla plans to file the marketing application after the completion of the ongoing clinical trials.
The EMEA initiated the review of the application for Riquent in June 2006.
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.
Riquent reduces the number of antibodies to double-stranded DNA that are associated with the progression of lupus renal disease. In all clinical trials Riquent treatment has significantly reduced these antibody levels. Data generated from the company’s previous phase trials indicated that patients with lower antibody levels experienced significantly fewer renal flares and improved quality of life.