GlaxoSmithKline and Human Genome Sciences announce FDA priority review designation for Benlysta

23-Aug-2010 - USA

GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc. announced that the U.S. food and Drug Administration (FDA) has granted a priority review designation to Benlysta® (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). 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 belimumab a Prescription Drug User Fee Act (PDUFA) target date of 9 December 2010.

The Biologics License Application (BLA) for belimumab was submitted to the FDA on 9 June 2010, and includes the results of two pivotal Phase 3 clinical trials that treated a total of 1,684 autoantibody-positive patients with SLE. HGS designed the Phase 3 programme for belimumab in collaboration with GSK and leading international SLE experts, and in consultation with the FDA.

“We are very pleased that FDA has chosen to grant priority review to belimumab, the first in a new class of drugs called BLyS-specific inhibitors,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We believe that the priority review designation speaks both to the significant medical need of people living with lupus and to the potential belimumab may hold as a new treatment option for these patients.”

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