Human Genome Sciences (HGS) and GlaxoSmithKline have announced that their groundbreaking new lupus treatment Benlysta has met its primary endpoints in trials and will be submitted for regulatory approval in early 2010.
Lupus is estimated to affect approximately five million people worldwide and no new treatment for the chronic life-threatening autoimmune disease has received approval in the last 50 years.
Results from the BLISS-76 Phase III trial in seropositive patients with systemic lupus erythematosus showed that belimumab 10mg/kg plus standard of care achieved a statistically significant improvement in patient response rate compared to placebo.
HGS president and CEO Thomas Watkins said that the BLISS-76 results confirm the companies' view that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus.
"We plan to submit marketing applications in the first half of 2010, following discussions with regulatory authorities in the US, Europe and other regions," Watkins said.
Study results also showed that belimumab was generally well tolerated with overall adverse event rates comparable between the belimumab and placebo treatment groups.
The BLISS-76 study is ongoing and will continue for 24 more weeks. Additional data will be available following completion of the full 76-week study period.