FDA approves first new drug for lupus in 56 years
Wednesday, March 9, 2011; 11:26 PM
WASHINGTON -- The Food and Drug Administration on Wednesday approved the first new drug to treat lupus in over 50 years, a milestone that medical experts say could prompt development of other drugs that are even more effective in treating the debilitating immune system disorder.
Known as Benlysta, the injectable drug is designed to relieve flare-ups and pain caused by lupus, a little-understood and potentially fatal ailment in which the body attacks its own tissue and organs.
Biotech drugmaker Human Genome Sciences Inc. spent 15 years developing Benlysta and will co-market it with GlaxoSmithKline PLC.
The companies estimate there are at least 200,000 lupus patients in the U.S. who could benefit from the drug.
But experts stress that Benlysta is not a miracle drug: It only worked in 35 percent of North American patients tested and was not effective for patients with the deadliest form of the disease. Additionally, it did not show positive results in African Americans, who are disproportionately affected by lupus.
FDA said in its news release it would require the drug developers to conduct another study exclusively in African Americans.
Dr. Betty Diamond, who has studied lupus for 30 years, said Benlysta should provide encouragement to researchers and drug developers.
"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," said Diamond, a researcher at the Feinstein Institute in New York.
Janice Fitzgibbon of McLean, Virginia has been taking Benlysta for two years as part of the drug's clinical trial program.
"It's given me my life back," she said, after being so crushed by pain that she couldn't take her dog for a walk or drive her children to school.
"It's a bittersweet thing for me because I have friends with lupus for whom this drug won't work," said Fitzgibbon, who is 54. "There's no one-size-fits-all for lupus and I'm just extremely fortunate that my lupus is mild and is helped by Benlysta."
FDA approved the drug for systemic lupus erythematosus, the most common form of the disease. Ten-year survival for patients diagnosed with the illness is more than 85 percent, according to the National Institutes of Health.