La Jolla’s MAA for Riquent Accepted by EMEA

La Jolla Pharmaceutical’s Marketing Authorization Application (MAA) has been accepted for review by the EMEA for potential approval to market Riquent, its drug candidate for lupus renal disease, in the EU.

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 EU authorization. Riquent also has orphan drug status and fast track status in the U.S.

The MAA filing includes data from the previously completed Phase III and Phase II/III trials of Riquent that showed patients treated with Riquent benefited by an increased time to renal flare compared to patients treated with placebo. Patients also showed reduced levels of antibodies, which experts believe are responsible for lupus renal disease. After one year of treatment, there was a statistically significant increase in the number of patients who had a 50% or greater reduction in protein in the urine, from baseline in the Riquent-treated group compared with the placebo-treated group. Treatment with Riquent has been well tolerated in all clinical studies.

In October 2004, the FDA informed the company that its NDA for Riquent was “approvable” pending the successful completion of a clinical benefit trial. The company is currently conducting a Phase III study under a Special Protocol Assessment (SPA) with the FDA, which is designed to further demonstrate Riquent’s ability to delay time to renal flare.