The FDA has told Genelabs Technologies that it will have to mount a new Phase III trial of its lupus drug Prestara before it can be approved, spurring the biotech company to signal its need for a collaborator to finance the work. Genelabs said it doesn't have the money needed to mount a new pivotal trial of the drug, which earned an "approvable" letter in 2002. As a result, company officials announced that they would either need a partner to sign on or would consider discontinuing or delaying further research into Prestara. Genelabs had been seeking FDA approval for the drug as a therapy used to prevent the loss of bone mineral density in women with the disease. It now says that seeking FDA approval as a therapy for the signs and symptoms of the disease would be more viable.
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