The company’s announcement is based on the outcome of a meeting with the FDA on March 11. La Jolla plans to continue the ongoing clinical benefit trial and expects to continue discussions with the FDA about ways to enhance the trial, including the addition of a higher dose to the study.
This decision follows a number of meetings with the FDA since October 2004, when La Jolla received an approvable letter from the FDA for Riquent (abetimus sodium). The approvable letter indicated that an additional trial demonstrating clinical benefit would be required prior to approval of Riquent and that an ongoing trial, initiated in August 2004, would appear to satisfy this requirement.
“We are disappointed that the FDA determined that accelerated approval is not applicable to the approval of Riquent,” stated Steve Engle, chairman and CEO of La Jolla. “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 US in almost 40 years.”