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news.La Jolla Pharmaceutical Company has received "fast track" designation from the FDA for Riquent for the treatment of lupus renal disease. However, the drug maker has warned that it may run out of money to complete its lupus program.
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In October 2004, the FDA informed La Jolla that Riquent (abetimus sodium) 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.
However, despite receiving the much needed time and money saving fast track designation, La Jolla currently only has limited financial resources and it has said that 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.
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. No new treatments have been approved in the US in almost 40 years.