Benlysta® (belimumab), a potential treatment for systemic lupus erythematosus has been granted a priority review designation by the FDA (Food and Drug Administration, USA), which is granted to medications, that if approved, offer significant treatment advances or provide treatment when no proper therapy exists. A PDUFA (Prescription Drug User Fee Act) has been assigned to belimumab, with December 9th as the target date.
Human Genome Sciences, Inc. and GlaxoSmithKline PLC submitted the The Biologics License Application (BLA) to the FDA on June 9th, which included the results of two pivotal Phase III studies involving 1,684 autoantibody-positive patients with systemic lupus erythematosus (SLE).
Human Genome Sciences designed the belimumab Phase 3 program in collaboration with GSK and leading international SLE experts, and in consultation with the FDA.
H. Thomas Watkins, President and Chief Executive Officer, Human Genome Sciences, said:
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. 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.
Marketing Authorization Application for belimumab had been submitted to the European Medicines Agency (EMA) on June 4th, 2010 by GlaxoSmithKline PLC.
GSK submitted a Marketing Authorization Application for belimumab to the European Medicines Agency (EMA) on June 4, 2010.
BENLYSTA® (belimumab)BENLYSTA is an investigational human monoclonal antibody drug. It is the first in a new class of drugs called BLyS-specific inhibitors that recognize and inhibit the biological activity of B-lymphocyte stimulator, or BLyS, which was discovered by Human Genome Sciences (HGS) in 1996. HGS and GlaxoSmithKline (GSK) are developing BENLYSTA under a co-development and commercialization agreement entered into in 2006. In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies - antibodies that attack and destroy the body's own healthy tissues. (more information on BENLYSTA)
Sources: Human Genome Sciences, GSK.
Written by Christian Nordqvist