La Jolla Pharmaceutical Company today announced that it has received "fast track" designation for Riquent (abetimus sodium) for the treatment of lupus renal disease from the U.S. Food and Drug Administration (FDA).
The FDA's fast track program is designed to facilitate the development and to expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address an unmet medical need.
In October 2004, the FDA informed the Company that Riquent was "approvable" pending the successful completion of a clinical benefit trial. A clinical benefit trial designed to meet this requirement was initiated in 2004 and is ongoing, although the Company has delayed further patient enrollment until additional funding is obtained.
The Company currently only has limited financial resources and if it does not receive funding from a collaborative agreement or obtain other financing in the near future, it will not have sufficient resources to complete the ongoing clinical benefit trial or to continue its operations beginning in the first quarter of 2006.
"Lupus represents one of the most significant unmet needs in medicine today, as currently available treatments are associated with significant side effects," said Steve Engle, Chairman and CEO of La Jolla Pharmaceutical Company. "No new treatments have been approved in the U.S. in almost 40 years."
Lupus, systemic lupus erythematosus or SLE, is a chronic, potentially life-threatening autoimmune disease. About 90% of lupus patients are female, and many develop the disease during their childbearing years. Approximately 50% of lupus patients have renal disease, which can lead to irreversible kidney damage, kidney failure and the need for dialysis, and is a leading cause of death in lupus patients. Latinos, African Americans and Asians face an increased risk of serious renal disease associated with lupus. 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.