The first new drug to treat lupus – a disease that disproportionately affects minorities – was approved this week, a milestone that was hailed in the lupus community.
The debilitating immune system disorder is commonly referred to as a women’s disease, and for reasons unknown disproportionately affects Hispanics, African Americans and Asians – those groups are twice as likely to get it than whites. The disease, a little-understood and potentially fatal ailment in which the body attacks its own tissue and organs, affects women nine times more often than men.
One in 500 Caucasian women is diagnosed with lupus, while one in 250 minorities are, said Dr. Anca Askanase of the New York University School of Medicine and the NYU Hospital for Joint Diseases.
While it’s still unclear the reason for the disparity, “it makes sense that there’s a strong genetic component to it,” Askanase told Fox News Latino.
This week, the Food and Drug Administration approved Benlysta, an injectable drug designed to relieve flare-ups and pain caused by lupus. It was the first new drug to treat lupus in 56 years.
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.
“I think it’s a big success for lupus patients,” Askanase said.
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.
Lupus causes fibrous tissue and inflammation of internal organs, skin rashes and joint pain. Most of Benlysta's benefit came from relieving muscle inflammation versus organ problems, as measured on a comprehensive checklist of lupus symptoms.
The disease occurs when the body's protector cells, known as antibodies, stop differentiating between foreign invaders, like bacteria, and healthy cells. The cause of this malfunction is not understood.
Currently most patients treat their disease with a variety of drugs that help ease inflammation, including painkillers, steroids and antimalarial drugs which were first approved for lupus in the 1950s. Many patients say the side effects of those treatments are nearly as uncomfortable as the disease itself. Steroids can cause bone fractures, weight gain and infection.
Wednesday's approval completes a remarkable turnaround for Rockville, Md.,-based Human Genome Sciences which has been developing Benlysta since 1996 and has no other products on the market. The company originally tested Benlysta, known generically as belimumab, as a treatment for rheumatoid arthritis.
When a mid-stage trial in lupus patients failed to meet researchers' goals in 2006, many analysts wrote the drug off and downgraded the company's stock. But when scientists reanalyzed the data they found that the drug helped block the antibodies that cause lupus symptoms in a subset of patients.
Analysts estimate the drug could reach annual sales exceeding $3 billion within five years.
The Associated Press contributed to this report.