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Wednesday
Mar092011

FDA Approves First Lupus Drug in 50 Years

Comstock/Thinkstock (WASHINGTON) -- The U.S. Food and Drug Administration on Wednesday approved Benlysta, the first lupus drug in half a century.

The drug, made by Human Genome Sciences Inc., is designed to lessen the severity of lupus, a little-understood disease in which the body's immune system attacks tissues and organs, producing skin rashes, joint pain, chronic fatigue and, in severe cases, heart and kidney complications.

Even though Benlysta has been shown to be only moderately successful in decreasing disease markers (an FDA advisory committee expressed some trepidation about its effectiveness last November), the dearth of other effective treatments makes Benlysta the hope of many a lupus researcher and patient.

"We still have a long way to go in understanding and treating lupus, but it's important to approve this right now. It really is the first drug for lupus to meet clinical endpoints [in decades]," says Dr. Betty Diamond, a lupus researcher who heads the Center for Autoimmune and Musculoskeletal Diseases at the Feinstein Institute.

Current standard of care for lupus includes high-dose steroids and anti-malaria medication to hamper the body's immune system. These medications can cause bone deterioration, infection, muscle weakness, ulcers and more, which, compounded with the symptoms of the disease itself, greatly hinder quality of life.

But even now that it has been approved, Benlysta will likely work in tandem with other lupus medications, and since Benlysta was not tested on patients with severe lupus in which the kidneys are heavily affected, it will most likely be prescribed only to those with mild to moderate disease.

Whether or not Benlysta will become the groundbreaking new treatment that many hope for, lupus experts were eager to see it approved.

"It's a long way from being a perfect drug, but I'll be interested to see if it can hold up as a usable drug," says Diamond.

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