RiquentTreatment for Systemic Lupus Erythematosus
La Jolla Pharmaceutical Company Receives Letter From FDA About Riquent
SAN DIEGO, October 14, 2004 -- La Jolla Pharmaceutical Company (NASDAQ:LJPC) 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.
La Jolla Pharmaceutical Company is a biotechnology company developing therapeutics for antibody-mediated autoimmune diseases and inflammation afflicting several million people in the United States and Europe. The Company is developing Riquent for the treatment of lupus kidney disease, a leading cause of sickness and death in patients with lupus. The Company is also developing LJP 1082 for the treatment of antibody-mediated thrombosis, a condition in which patients suffer from recurrent stroke, deep-vein thrombosis, miscarriage and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions. The Company's common stock is traded on The Nasdaq Stock Market under the symbol LJPC.
For more information, please visit www.ljpc.com.
Posted: October 2004
- La Jolla Pharmaceutical Announces Outcome of Recent FDA Discussions - March 14, 2005
- La Jolla Pharmaceutical’s New Drug Application for Lupus Drug Candidate Riquent Accepted for Review by FDA - February 17, 2004