Benlysta: First New Lupus Drug Approved in 50 Years

The Food and Drug Administration Wednesday approved the first new drug in more than 50 years for the treatment of lupus, offering patients a less-toxic way to manage the debilitating disease.

The injectable drug, Human Genome Sciences’ belimumab, has been shown to be only moderately effective at relieving symptoms of systemic lupus erythematosus, a chronic inflammatory disease that causes the body’s immune system to attack healthy tissues and organs. And the drug does not appear to work well in African Americans, a finding that will require further study.

But belimumab appears to carry fewer side effects than current treatments and may allow patients to reduce the amount of steroids and immune-suppressing drugs that they take, said Dr. Robert S. Katz, a professor of medicine at Rush University Medical College.

"I’m not sure, for patients who are very sick, that this is going to work as well as existing things. But existing things are very toxic," said Katz, whose patients were involved in clinical trials of the drug. "It’s exciting that something new is coming out, but it’s going to have to fight for its place."

Sandra C. Raymond, president of the Lupus Foundation of America called the FDA’s approval "historic" and said it "marks the beginning of a new era of improved diagnosis, prevention, and treatment for the disease."

The FDA approved belimumab for use with standard therapy for lupus, which includes corticosteroids, immune-suppressing drugs and anti-malarial drugs.

Belimumab, which will be co-marketed with GlaxoSmithKline as Benlysta, is expected to be a blockbuster drug when it arrives on the market.

Lupus affects an estimated 1.5 million Americans, including approximately 65,000 in Illinois, according to the Lupus Foundation of America. Young women are disproportionately affected.

Symptoms include joint pain, fatigue, fevers and skin rashes.

Commonly-prescribed medications can minimize these symptoms, but they often carry serious side effects of their own. Corticosteroids, for instance, can cause weight gain, bone loss and high blood pressure.

The most common side effects associated with belimumab in a pair of clinical trials were nausea, diarrhea and fever.

from the Chicago Sun Times, March 10, 2011

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