New Lupus Drug Wins FDA Approval

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.

Lupus patients have long struggled to draw attention to their disease, which affects women nine times more than men. African Americans are three times more likely to have the disease.

"I don't think there's a conspiracy here, but it just hasn't gotten a lot of funding and it hasn't gotten a lot of attention from the media," said Dr. Abby Abelson, chair of the Department of Rheumatologic and Immunologic Disease at the Cleveland Clinic.

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 1955. 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.

Human Genome Sciences' stock has ballooned in the last two years — from 70 cents to roughly $25 per share — as the company's prospects have improved. Trading in its shares was halted pending the release of the FDA news after the market's close Wednesday. GlaxoSmithKline shares rose $1.36, or 3.5 percent, to $39.94 in extended trading.

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  • by Audra Location: SoCal on Mar 12, 2011 at 10:05 AM
    I have friends in my support groups that have Lupus Nephritis, & are on Cellcept. I also know a couple of people now with MG. It has helped a lot of people & you know I think that you and Maggie Belle did something amazing, along with the others involved. There has been a ripple of disappointment in the Lupus community from those finding that it is not their miracle, as it doesn't treat severe forms w/ organ involvement. I had to point out however that it is still a step in the right direction - the first in longer than I've been alive - & will still help many that are suffering debilitating pain. Steroids aren't a good solution, so this may be a miracle for *some*. Remicade (another infusion med) has done that for many as well. Each newly cracked genetic key, each new tidbit of understanding, & surely the gift of those receiving experimental treatments gets us closer to a cure. As I pointed out to one person, we may not see it happen but someone will.. & yes, cost will ease over time.
  • by Obama Snake Oil Co Location: Washington on Mar 11, 2011 at 05:15 AM
    Audra, you know I can relate to this story having taken care of the myathenia gravis test dog for Roche. Cellcept doesn't work for everybody either, however, it improves the quality of life for so many, it was worth it. The tears of loss, are outweighed by the tears of joy when I have met people that walk normal, for the first times in their lives. I think, like Cellcept and Roche, the price will come down with world demand. God bless you for you with your struggle, the glass is now half full...take care, OSOC
  • by Audra Location: SoCal on Mar 10, 2011 at 12:39 PM
    That whole Seinfeld thing is idiotic & insulting. George is afraid he will "contract" Lupus? It's genetic, not communicable. Stephanie, sorry about your friend. The disease isn't as directly a short death sentence as it was 25 to 50 yrs ago, as there have been improvements in detection, diagnosis, & treatment. It is however still a frustrating and debilitating struggle... and it still claims lives. People like you that can go through life informed and helping to improve awareness are a blessing.
  • by Stephanie Location: Winterville on Mar 10, 2011 at 07:56 AM
    This is great news! I lost my best friend to this disease at age 25. While this drug doesn't help everyone, it does give us hope that there is something out there that can be done. Keep faith and inform people of this disease so that it can get the research funds it needs.
  • by booger Location: enc on Mar 10, 2011 at 06:20 AM
    Lupus?....Is it Lupus? - George Costanza
  • by Audra Location: SoCal on Mar 10, 2011 at 01:18 AM
    On the one hand, I'm ecstatic that this FINALLY happened. The projected date was in December & it's had one delay after another. So.. YAY, it went through! On the other hand, it's sad that it's taken so many yrs, and that the cost is so high. They've said all along "about $20K a year". Now I'm hearing about $3500 a dose, once a month, but that adds up to $42K.. so I don't know. I'm thankful there are better answers coming now, for those able to take this medication, & hope it will lead to more research & better answers for more of us.. as it won't be the right med for everyone. There is supposed to be another in development stages already. A set of meds that don't carry risks like retinopathy (& blindness) as the anti-malarials do would be a godsend for many. There are always side effects & trade-offs to consider, but the worst thing is a lack of choices. Thank you WITN for posting this story. Awareness promotes involvement & potentially improves our quality of life.

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