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SAN DIEGO, June 22 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company (Nasdaq: LJPC) today announced that its Marketing Authorization Application (MAA) has been accepted for review by the European Medicines Agency (EMEA) for potential approval to market Riquent(R) (abetimus sodium), its drug candidate for lupus renal disease, in the European Union (EU). The MAA was filed with the EMEA on March 31, 2006.
The EMEA's review of the application will follow their centralized marketing authorization 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 ten years of market exclusivity from the date of EU authorization. Riquent also has orphan drug status and fast track status in the United States.
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 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," said Deirdre Y. Gillespie, M.D., President and CEO of La Jolla Pharmaceutical Company. "It is also a major milestone in our focused corporate effort to guide Riquent toward full approval in Europe and the United States. We anticipate that the EMEA's initial response and questions concerning our application will come later this year, and a final decision should come in 2007."
The MAA filing includes data from the previously completed Phase 3 and Phase 2/3 clinical trials of Riquent, in which treatment with Riquent was assessed for its ability to increase time to renal flare in comparison to placebo. A renal flare is caused by inflammation in the kidney that destroys kidney tissue and/or reduces or stops kidney filtration. Renal flare can result in the progression to end-stage renal disease, the need for dialysis, or death.
* In both trials, patients treated with Riquent benefited by an increased time to renal flare compared to patients treated with placebo, although the results did not reach statistical significance as defined in the protocols.
* Riquent treatment reduced levels of antibodies to double-stranded DNA (dsDNA), which experts believe are responsible for lupus renal disease. In both trials, patients with sustained reductions in antibodies to dsDNA experienced a statistically significant reduction in the number of renal flares.
* After one year of treatment, there was a statistically significant increase in the number of patients who had a 50% or greater reduction in proteinuria from baseline in the Riquent-treated group compared with the placebo-treated group. Proteinuria, or protein in the urine, results from ongoing kidney inflammation.
* Treatment with Riquent has been well tolerated in all clinical studies.
In October 2004, following a review of the Company's New Drug Application for Riquent, the U.S. Food and Drug Administration (FDA) informed the Company that Riquent was "approvable" pending the successful completion of a clinical benefit trial. The Company is currently conducting a Phase 3 study under a Special Protocol Assessment with the FDA, which is designed to further demonstrate Riquent's ability to delay time to renal flare.
About Riquent
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 has been well tolerated in all of these studies, with no serious side effects identified to date. Riquent's only known biological activity is the reduction of antibodies to dsDNA that are associated with the progression of lupus renal disease and renal flares. In all clinical trials where antibodies to dsDNA were measured, Riquent treatment has significantly reduced these antibody levels. Data generated in the Company's previous Phase 2/3 and Phase 3 trials indicate that patients with lower antibody levels experience significantly fewer renal flares and improved health-related quality of life.
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