La Jolla's Riquent for lupus renal disease under review by European Medicines Agency

By Lisa Kerner

Charlotte, N.C., June 22 - La Jolla Pharmaceutical Co. said its Marketing Authorization Application to market Riquent (abetimus sodium), its drug candidate for lupus renal disease, in the European Union, has been accepted for review by the European Medicines Agency (EMEA).

If approved, Riquent will receive marketing authorization in all 25 E.U. member states, Norway, Iceland and Liechtenstein.

The MAA filing includes data from LaJolla's completed phase 3 and phase 2/ 3 clinical trials assessing Riquent's ability to increase time to renal flare (inflammation) compared to a placebo.

While patients treated with Riquent benefited by an increased time to renal flare compared to patients treated with a placebo, the results did not reach statistical significance.

Treatment with Riquent has been well-tolerated in all clinical studies, the company said.

Riquent has already received orphan medicinal product designation in Europe as well as orphan-drug and fast-track status in the United States.

"The acceptance of our MAA filing is a significant step toward our goal of providing a safer treatment to patients who suffer both from lupus renal disease and from the side effects of current therapies used in its treatment," president and chief executive officer Deirdre Y. Gillespie said in a company news release.

The company said it expects EMEA's final decision in 2007.

Lupus, systemic lupus erythematosus or SLE, is a chronic, potentially life-threatening autoimmune disease affecting millions of people worldwide, half of which have renal disease.

San Diego-based La Jolla Pharmaceutical develops therapeutics for antibody-mediated autoimmune diseases and inflammation.

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