US regulatory approval for a new self-injectable form of Benlysta

The US Food and Drug Administration has approved a new subcutaneous formulation of Benlysta (belimumab) for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy, the drug’s maker GlaxoSmithKline (LSE: GSK) announced on Friday.

Systemic Lupus Erythematosus (SLE) is the most common form of lupus, a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body. The approval marks the first subcutaneous self-injection treatment option for patients with SLE.

Earlier this year GSK said it is investing $139 million in its biopharmaceutical manufacturing site in Maryland, USA, to support growing demand for Benlysta. The drug generated sales of $377 million in sales in the USA in 2016.