Benlysta has become the first medicine in the US approved for children with lupus after GSK gained the green light from the FDA.
The IV formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, has been approved under priority review.
“This accelerated decision means children in the US now have an innovative, FDA-approved medicine available to help manage the impact of living with this challenging autoimmune disease,” said Dr Hal Barron, Chief Scientific Officer and President of R&D at GSK.
The approval extends the current indication in the US for the IV formulation of Benlysta in adults to patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
Benlysta was approved in the US in March 2011 for adults and is currently the only medicine specifically approved in the US for both adults and children with SLE.
The IV formulation of Benlysta is currently not approved for use in children anywhere else in the world although regulatory submissions are ongoing in other parts of the world.