LONDON The Food and Drug Administration has decided to expedite the review of an investigational drug made by GlaxoSmithKline and Human Genome Sciences for an autoimmune disorder, the two companies said Thursday. The companies submitted a regulatory approval application to the agency in early June.
The FDA granted priority review designation to Benlysta (belimumab) as a treatment for systemic lupus erythematosus, often simply called lupus, an inflammatory disorder that affects the internal organs, joints and skin, and can be fatal in its severest forms. The FDA grants the designation to drugs that address life-threatening conditions or provide therapeutic options where no adequate ones exist.
“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,” HGS president and CEO H. Thomas Watkins said.