Human Genome Sciences and GlaxoSmithKline have been granted a priority review designation for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus (SLE). The FDA has assigned belimumab a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010.
The BLA for belimumab was submitted to the FDA on June 9, 2010, and includes the results of two Phase III trials that treated a total of 1,684 autoantibody-positive patients with SLE. HGS designed the Phase III program for belimumab in collaboration with GSK, 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.”
Carlo Russo, M.D., senior vice president, Biopharm Development, GSK, said, “Belimumab is the first medicine for lupus that has completed Phase III trials with positive results. We look forward to continuing to work together with HGS to progress regulatory files and we hope that we will be able to deliver a new treatment option for patients living with lupus.”