Update on Lupus treatment

The FDA is expected to issue an approval decision on October 16 regarding La Jolla Pharmaceutical's drug Riquent to treat lupus kidney disease.

The decision is a significant one because, if Riquent is approved, it will represent the first FDA approval of a drug to treat lupus in more than 35 years, and the first drug approved since the FDA's move to better define approval guidelines for lupus drugs.

Lupus is an autoimmune disease that affects about 1m people in the US and Europe - 90% women, many of whom are diagnosed during their childbearing years. Half of those patients have lupus kidney disease, which is the leading cause of sickness and death in lupus patients. Until now, lupus patients have relied on drugs such as corticosteroids and chemotherapy to treat their symptoms, and these treatment options lead to toxic side effects including sterility, increased risk of cancer, bone loss, diabetes and increased risk of opportunistic infections.

Riquent is specifically designed to reduce certain antibodies that cause lupus kidney disease, and it has done so in clinical studies without significant side effects. Riquent is the most advanced drug candidate for lupus, but there are also other treatments in development. Phase III clinical data with Prestara, a hormone developed by Genelabs for the treatment of bone loss that is a side effect of the steroids used to treat lupus, is expected in the fourth quarter of 2004. Additionally, Human Genome Sciences recently completed enrollment in a Phase II clinical trial for their lupus drug LymphoStat-B, and Genentech is working on clinical trials to determine the efficacy of their drug Rituxan against lupus.