Approvable letter for Riquent
San-Diego based La Jolla Pharmaceutical has received a letter from the FDA indicating that its lupus drug candidate, Riquent (abetimus sodium), is approvable, but that an additional randomised, double-blind study demonstrating the clinical benefit of Riquent would need to be completed prior to approval.
San-Diego based La Jolla Pharmaceutical has received a letter from the FDA indicating that its lupus drug candidate, Riquent (abetimus sodium), is approvable, but that an additional randomised, 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.
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 antibodymediated thrombosis, a condition in which patients suffer from recurrent stroke, deepvein thrombosis, miscarriage and other thrombotic events, and is in the early stage of developing small molecules to treat various other autoimmune and inflammatory conditions.