It is a milestone that medical experts say could prompt development of other drugs that are even more effective in treating the debilitating illness.
Known as Benlysta, the injectable drug is designed to treat flare-ups and pain caused by lupus, a little-understood disorder in which the body attacks its own tissue and organs.
Biotech drugmaker Human Genome Sciences spent 15 years developing Benlysta and will co-market it with GlaxoSmithKline.
But experts stress that Benlysta is not a miracle drug: It only worked in a subset of patients and was not effective against the deadliest forms of the disease. Additionally, it did not work in African Americans, who are disproportionately affected by lupus.
