GlaxoSmithKline PLC (GSK) and Human Genome Sciences, Inc (HGSI). announced that the US 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 December 9, 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.”
Carlo Russo, M.D., senior vice president, Biopharm Development, GSK, said, “Belimumab is the first medicine for lupus that has completed Phase 3 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.”
GSK submitted a Marketing Authorisation Application for belimumab to the European Medicines Agency (EMA) on 4 June 2010.
In 2006, HGS and GSK entered into a definitive co-development and commercialisation agreement under which HGS has conducted the belimumab phase 3 trials, with assistance from GSK. The companies will share equally in phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialised under the agreement.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.