SAN DIEGO, Oct. 14 /PRNewswire-FirstCall/ -- La Jolla Pharmaceutical Company (Nasdaq: LJPC - News) announced today that the Company has received a letter from the United States Food and Drug Administration (FDA) indicating that its lupus drug candidate, Riquent® (abetimus sodium), is approvable, but that an additional randomized, double-blind study demonstrating the clinical benefit of Riquent would need to be completed prior to approval. The FDA letter indicated that the ongoing clinical trial initiated in August 2004 would appear to satisfy this requirement.
The Company continues to review the letter and has requested a meeting with the FDA to discuss the next steps in the development of Riquent. Until that meeting is held, the Company will be able to provide only limited guidance.
Source: La Jolla Pharmaceutical Company