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FDA Approves First New Lupus Drug In 50 Years

March 10, 2011

The US Food and Drug Administration (FDA) has approved Benlysta, making it the first new treatment for lupus to receive the agency’s blessing in five decades.

Benlysta is a drug that is taken by injection once per month. It is designed to help relieve pain and reduce the severity of symptoms associated with lupus–the mysterious disease in which the body’s immune system turns on itself, attacking tissues and organs and leading to joint pain, chronic fatigue, arthritis, skin rashes, and in some cases, even heart and kidney damage.

Currently, the condition is treated with a combination of steroids and anti-malaria medication, but according to Courtney Hutchinson of the ABC News Medical Unit, those treatments “can cause bone deterioration, infection, muscle weakness, ulcers and more, which, compounded with the symptoms of the disease itself, greatly hinder quality of life.”

Despite its approval, however, “experts stress that Benlysta is not a miracle drug,” says AP Health Writer Matthew Perrone. According to Perrone, the drug only worked on 35% of the North American patients who used it during a clinical trial, and it “did not show positive results in African Americans, who are disproportionately affected by lupus.”

The AP says that the FDA has ordered the drug’s developers, Human Genome Sciences Inc., to conduct an additional study with only African-American participants, for further information.

Fifty-four year old Virginia resident Janice Fitzgibbon, one of the participants in the trial, told Perrone that the drug “[has] given me my life back,” but added that Benlysta’s approval was “a bittersweet thing for me because I have friends with lupus for whom this drug won’t work.”

According to Reuters reporter Lisa Richwine, one company-funded trial demonstrated that patients given a high dose of Benlysta along with traditional lupus treatments felt relief and suffered no additional organ damage following a one-year treatment period. Only 34% of those taking a placebo along with standard therapies reported similar results.

“We still have a long way to go in understanding and treating lupus, but it’s important to approve this right now,” Dr. Betty Diamond of the Center for Autoimmune and Musculoskeletal Diseases at the Feinstein Institute for Medical Research told ABC News.

“It will send out the message that it’s possible to conduct a successful clinical trial in lupus and that’s tremendously important to keep the pharmaceutical industry interested in this disease,” Dr. Diamond added in a separate interview with Perrone.

Benlysta will cost the average lupus patient about $35,000 annually, Richwine said. Analysts predict that the drug will top the $3 million mark in annual global sales by 2015 and could eventually exceed $5 million in worldwide sales each year, the Reuters reporter added.

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