Clinical Trials

Pharmaceutical company unlikely to receive accelerated approval for lupus drug

Published in Medical Letter on the CDC and FDA, April 17th, 2005

La Jolla Pharmaceutical Company (LJPC) announced that, based on the outcome of a meeting with the U.S. 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...

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Source: Medical Letter on the CDC and FDA (2005-04-17)

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