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NDA Submitted for Riquent To Treat Lupus Renal Disease
"Our New Drug Application for Riquent is supported by data from two of the longest and largest randomized clinical studies ever conducted to evaluate a drug candidate in lupus patients," said Steve Engle, Chairman and CEO of La Jolla Pharmaceutical Company. "We believe these studies show that patients treated with Riquent experienced reductions in the levels of antibodies to dsDNA and that reductions in these antibodies were associated with fewer renal flares. These results were seen even though many patients were on immunosuppressive drug therapies."
Engle added, "This submission represents an important milestone for the Company and a potentially significant advance for lupus patients in combating their disease."
New Drug Application
The evidence supporting the safety and effectiveness of Riquent is derived from 12 clinical trials involving approximately 900 patients and subjects conducted over a period of approximately 10 years. The submission is primarily based on previously announced data from the Company's Phase 3 trial of Riquent that enrolled 298 patients with high-affinity antibodies to Riquent who were treated for up to 22 months and its Phase 2/3 trial that enrolled 189 high-affinity patients who were treated for up to 18 months. The trials focused on the leading causes of sickness and death in lupus patients: renal flares and treatments with immunosuppressive drugs.
About Lupus and Riquent
Lupus is a chronic, life-threatening autoimmune disease afflicting approximately one million people in the United States and Europe. About 90% of lupus patients are female. Most patients develop the disease during their childbearing years. Approximately 50% of lupus patients have renal disease. Renal disease is one of the most serious aspects of lupus and can lead to irreversible kidney damage, kidney failure and the need for dialysis. Antibodies to dsDNA can be detected in most lupus patients and are considered diagnostic for the disease.
The current standard of care for lupus renal disease often involves treatment with high doses of corticosteroids and immunosuppressive drugs that can cause severe side effects including diabetes, hypertension and sterility, and may leave patients vulnerable to opportunistic infections. The morbidity resulting from current treatments can be worse than the disease itself.
Riquent is designed to be highly specific and not to suppress the normal healthy functions of the immune system. Riquent appeared to be well tolerated in all studies with no apparent differences in the overall incidence of serious adverse events or adverse events between Riquent-treated and placebo-treated patients.
Source: Jolla Pharmaceutical Company