At the end of a day of often emotional testimony, an FDA advisory panel overwhelmingly voted to recommend the approval of a new drug for the treatment of systemic lupus.
If the FDA follows the panel’s advice, the drug, belimumab, will be the first drug approved in more than 50 years for the chronic and debilitating autoimmune disease.
Despite the 13-2 vote in favor of approval, no member of the Arthritis Advisory Committee considered belimumab — to be marketed as Benlysta — a wonder drug.
“It has a weak effect, but they made the case,” panelist Matthew Liang, MD, MPH, a professor of medicine at Harvard, said of the data supplied by the drug’s manufacturer, Human Genome Sciences.
Systemic lupus erythematosus (SLE) causes the body’s immune system to attack healthy cells and tissues. Over time, it can damage the kidneys, heart, lungs, and other organs. Among its most common symptoms are extreme fatigue and swollen, painful joints.