Genelabs Technologies Inc announced that the Marketing Authorization Application (MAA) for its investigational lupus drug, Prestara (prasterone, GL701), has been submitted to the European Agency for Evaluation of Medicinal Products (EMEA). The submission has been made under the EMEA Centralized Procedure which provides for simultaneous consideration of the MAA in 17 European countries through a single centralized review and decision. If approved, Genelabs' lupus drug will be marketed in Europe under the trade name Anastar.
"This submission marks another important milestone for Genelabs related to the development and commercialization of our lead product," said Irene A. Chow, chairman and chief executive officer. "There is a significant need for new lupus therapies in Europe, just as there is in the United States and the rest of the world. We believe Anastar can become a valuable addition for the care of women suffering from this debilitating disease. To commercialize Anastar in Europe, we plan to enter into a relationship with an established pharmaceutical company, and are in active discussions with companies that are interested in licensing the European marketing rights."
Genelabs' MAA requests approval of Anastar for the improvement of systemic lupus erythematosus (SLE or lupus) disease activity and/or reduction in glucocorticoid doses in women with active SLE. The submission is based primarily on data from two Phase III double-blind, randomized, placebo-controlled clinical trials (GL94-01 and GL95-02) that together compared prasterone to placebo in 572 women with mild to moderate lupus.
Genelabs' first Phase III clinical trial, Study GL94-01, was designed to determine whether prasterone would allow steroid-dependent women with lupus to reduce their steroid (prednisone) dose to 7.5 mg per day or less (a near-physiologic level) and sustain the dose at that level while either improving or stabilizing their disease activity. The second Phase III clinical trial, Study GL95-02, was designed to determine whether prasterone would improve or stabilize SLE disease activity and/or its symptoms in women with clinically active disease. Included in this clinical trial was a nested study measuring the effect of prasterone on bone mineral density of patients on glucocorticoids.