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FDA Decides Riquent Not a Candidate for Accelerated Approval
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 accelerated 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."
Source: La Jolla Pharmaceutical Company