The injectable drug, Benlysta, relieves flare-ups and pain.
This milestone could prompt the development of other drugs that are even more effective in treating the disorder, medical experts say.
Lupus is a potentially fatal auto-immune disease that causes the body to attack its own tissue and organs.
The Centers for Disease Control and Prevention estimates up to 1 1/2 million Americans have some form of lupus.
The Associated Press contributed to this story