Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline PLC (GSK, GSK.L) announced Thursday that BENLYSTA has been granted a priority review designation by the U.S. Food and Drug Administration or FDA. The regulatory body granted the designation to BENLYSTA as a potential treatment for systemic lupus erythematosus.
A priority review designation is granted to drugs that, if approved, offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA has assigned a Prescription Drug User Fee Act target date of December 9, 2010.
The Biologics License Application was submitted to the FDA on June 9, 2010, and GSK submitted a Marketing Authorization Application to the European Medicines Agency on June 4, 2010.
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