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Format: 04/19/2014
Format: 04/19/2014

News

FDA Approves First New Lupus Medication in Five Decades

Thursday, March 10th, 2011

The Food and Drug Administration has approved the first new drug therapy for lupus in 52 years, providing a less toxic treatment option that could be life-changing for many patients.

The new drug, Benlysta (belimumab), is expected to be available for consumers within two weeks, according to drug makers Human Genome Sciences and GlaxoSmithKline.

“This approval stands to significantly improve the quality of life for patients with active lupus,” said Susan Manzi, MD, Co-Director of The Lupus Center of Excellence at West Penn Allegheny Health System (WPAHS).

Dr. Manzi participated in the design of the Benlysta trials. Results of the trials showed that patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines.

“For many patients, this new drug will bring much needed relief from disease flare ups without organ damage and other side effects associated with current standard treatments like steroids,” Dr. Manzi said.

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues, causing symptoms such as swelling, joint pain, light sensitivity, fever, chest pain, hair loss, and extreme fatigue. Lupus affects men and women of all ages but is most common among women in their child-bearing years.

The Lupus Foundation of America (LFA) estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus. Lupus is two- to three times more prevalent in women of color than in Caucasian women, the LFA says.

Results from the initial trials of Benlysta suggested that the drug may not be as effective in treating patients of African heritage, but few African Americans were enrolled in those studies. Further testing will be done in this subgroup of patients to determine Benlysta’s usefulness in treating African Americans.

“We hope that the success that patients can experience with Benlysta will translate into a renewed interest in research efforts to refine it and develop additional lupus therapies,” said Fotios Koumpouras, MD, Medical Director of The Lupus Center of Excellence at WPAHS. Dr. Koumpouras treats patients who were part of the Benlysta trials.

“Research that will bring us closer to a cure has always been a central focus of what we do at The Lupus Center of Excellence and it’s fulfilling to see that research yield a breakthrough that will improve patient care.”

The Lupus Center of Excellence at WPAHS is dedicated to providing comprehensive care that improves the quality of life for lupus patients.

Combined, the Center’s physicians, nurses, researchers and other professionals have more than 150 years of expertise in the causes, symptoms and treatment of lupus and related autoimmune disorders.

Lupus Center of Excellence physicians have participated in every major new drug trial for systemic lupus in the last decade. The Center’s research has yielded new testing methods that can lead to earlier and more accurate diagnosis of lupus and improve our ability to predict and treat flare-ups in lupus patients.

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