Genelabs Technologies has announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase III clinical trial of Prestara (prasterone) for treatment of systemic lupus erythematosus (lupus).
The SPA documents the FDA's agreement that the design and planned analyses of the study adequately address objectives in support of a New Drug Application (NDA) submission. The FDA has further indicated to Genelabs that a positive outcome to the proposed new Phase III study in addition to evidence of efficacy from previous trials of Prestara and an overall positive risk/benefit assessment would in principle meet FDA standards for NDA approval.
"We are delighted to have reached agreement with the FDA under an SPA that this phase III clinical trial, if successful, together with the totality of data contained in Genelabs' NDA for Prestara, can meet the FDA's standards for NDA approval," stated James A. D. Smith, Genelabs President and Chief Executive Officer. "FDA has earlier designated the Prestara NDA approvable and a previously completed phase III clinical trial of Prestara in lupus has been agreed by the FDA as being positive adequate and well-controlled. Now, having reached agreement with the FDA on an SPA for a new phase III trial, we have a clear regulatory pathway for Prestara in the U.S. Genelabs is actively seeking strategic partnering for project financing, which needs to be secured in order to initiate this new phase III Prestara clinical trial. We view the SPA agreement as an important factor in moving these activities forward."