FDA Approves First New Lupus Drug In 56 Years

Lupus Varrucosus

Lupus Varrucosus

Via Modern Medicine:

Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat lupus, the first medication sanctioned for the condition in the United States since 1955.

The injected drug targets B-lymphocyte stimulator (BLyS) protein, which is believed to play a role in abnormal B cells thought to characterize lupus, the agency said in a news release. Lupus disproportionally affects women, usually aged 15 to 44.

As many as 1.5 million people in the United States have the disease, although estimates vary widely, the FDA said. Black women have a three times higher incidence of the disease than Caucasian women.

The safety and effectiveness of Benlysta were established in a pair of clinical studies involving 1,684 people. Those treated with Benlysta had fewer symptoms than those who took a placebo, and the results suggested that those who took the drug also were less likely to have severe lupus flares, the agency said.

[Continues at Modern Medicine]