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news.Biopharmaceutical company Genelabs is considering delaying or abandoning development of its phase III lupus candidate Prestara after the FDA told the company that further trials would be required before it could evaluate the drug for marketing approval.
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Genelabs is currently working with the FDA in designing an additional trial for the drug in its indication for treating the signs and symptoms of lupus, although the company admits that it may not be able to complete the necessary trial.
A statement released by the company read: “Because the company currently does not have sufficient funds to conduct another clinical study of Prestara on its own, if an additional clinical trial is conducted it would likely be in conjunction with a new or existing collaborator, or, alternatively, Genelabs may have to delay or discontinue future development of Prestara.”
The company also discussed with the FDA its options for pursuing an indication of prevention of loss of bone mineral density (BMD) in women with lupus, an indication that Genelabs has pursued since receiving an approvable letter for its Prestara new drug application in 2002.
However, the FDA stated that additional positive prospective phase III clinical trial data would also be necessary before it would consider reviewing the NDA for the drug in this indication.
Based on this interaction with the FDA, Genelabs believes that pursuit of an indication for treating the signs and symptoms of lupus is a more viable route forward for Prestara than an indication for prevention of BMD loss in lupus.