La Jolla Pharmaceutical Company recently announced that, based on the outcome of a meeting with the United States Food and Drug Administration (FDA) on March 11, 2005, its treatment for lupus renal disease, Riquent® (abetimus sodium), is unlikely to receive an accelerated approval under the FDA’s Subpart H regulation. The Company plans to continue the ongoing clinical benefit trial and expects to continue discussions with the FDA about ways to enhance the trial, including, as previously announced, the addition of a higher dose to the study.
This decision follows a number of meetings with the FDA since October 2004, when the Company received an Approvable Letter from the FDA for Riquent. The Approvable Letter indicated that an additional trial demonstrating clinical benefit would be required prior to approval of Riquent and that the company’s ongoing trial, initiated in August 2004, would appear to satisfy this requirement.
“We are disappointed that the FDA determined that accelerate approval is not applicable to the approval of Riquent,” stated Steve Engle, Chairman and CEO of La Jolla Pharmaceutical Company. “We recognize the urgent need for safer and more effective treatments for lupus patients, as no new drugs have been approved for this disease in the United States in almost 40 years.”