Genelabs Technologies Inc announced that it has decided to withdraw its European Marketing Authorization Application (MAA) for its investigational lupus drug, Anastar (prasterone, Prestara in the United States). Earlier, Genelabs had received a list of questions from The European Medicines Agency (EMEA), which are to be addressed by the company at an oral explanation scheduled for July 2004, after being postponed from May 2004. The current assessment of the EMEA is that the data submitted in the MAA are not sufficient for approval.
"We are disappointed that withdrawal of the MAA is necessary at this time," stated James A.D. Smith, president and CEO. "However, we remain confident in the benefits of Anastar for women with lupus and will work with the EMEA to address the remaining issues so that we can resubmit the application in the future," he added.
"Developments related to Genelabs MAA in Europe do not affect the approvable status of our Prestara New Drug Application in the United States," continued Mr. Smith. Results from the trial are expected to be available during the fourth quarter of this year. If our New Drug Application for Prestara is approved by the FDA, our North American commercial partner, Watson Pharmaceuticals, will be able to commence marketing Prestara in the United States where lupus patients and their physicians would then have the first new therapeutic option for this disease in over forty years," he added.