By Diedtra Henderson, The Boston Globe
Feb. 19–WASHINGTON — For patients suffering from a severe form of Crohn’s disease, a remedy already on the shelf to treat other maladies and a brand-new drug could offer new hope.
Within days, Illinois-based Abbott Laboratories expects to win federal approval to sell its drug, Humira, currently used to treat rheumatoid arthritis, psoriatic arthritis, and a disease that causes arthritis of the spine, to combat the intestinal disorder.
The new use could produce up to about $500 million in annual revenue for a drug that is produced at Abbott’s facility in Worcester.
Some 600,000 North Americans suffer from Crohn’s, a chronic, inflammatory disease of the gastrointestinal tract.
The ailment is marked by debilitating flares that trigger diarrhea, cramping, loss of appetite, and weight loss.
It’s a “wonder disease,” jokes Judi Walk, of Needham, “because you’re always wondering why you’re sick. You can be fabulous one morning and sick as a dog that night,” said Walk, 63, who has struggled with Crohn’s symptoms since she was a teenager.
“When you have a flare-up, you’re basically knocked into bed,” Walk said. “A serious flare-up can stop your life.”
Dr. Adam S. Cheifetz, who treats patients with Crohn’s, said only two-thirds respond to Centocor Inc.’s Remicade , the first biologic treatment approved by the Food and Drug Administration for adults with moderate to severe Crohn’s. Even those who do respond can build resistance to Remicade over time.
“The biggest difference this is going to make is for those people who had been doing well on Remicade, and then lost their response. That was a problem group of patients,” said Cheifetz, clinical director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center. “For those patients we would normally put on Remicade, now we have two drugs to choose from.”
In clinical trials, 21 percent of patients who had stopped responding to Remicade were coaxed into remission by week four on Humira, compared with 7 percent who achieved remission on a placebo. Those results were impressive enough for the FDA to speed its handling of the drug — trimming the review from 10 months to six months and indicating that an approval decision could come by the end of February.
Because the FDA has already approved Humira for other uses, doctors and patients would be able to purchase it immediately after FDA approval, for roughly $600 per syringe wholesale, or $16,000 per year, according to Abbott spokeswoman Elizabeth Shea.
People with Crohn’s are often diagnosed between the ages of 15 and 30, a “young and active patient population,” said Shea, who added that Humira’s other selling point for people who plan their lives around trips to the bathroom is the ease of being able to self-administer the drug at home.
Cowen and Co. analysts factored that into their projection that Humira would become a $4.3 billion worldwide seller by 2010 and the dominant injectable Crohn’s drug in the United States, besting UCB Pharma’s once-monthly Cimzia , an experimental drug that is also expected to receive FDA approval this year.
For patients like Lauren Whelihan , a 25-year-old who was home-schooled because she was too sick to attend high school, the new drugs are a godsend. Whelihan already has had two surgeries that removed much of her large intestine. For now, Remicade works, and the Westfield State College student is in her longest remission ever.
But Whelihan is already planning for a future when Remicade might not work. “It never hurts to have more options with a disease like this,” she said.
A third possible option for Crohn’s patients is Biogen Idec’s multiple sclerosis therapy Tysabri.
Tysabri was greeted with excitement because of its ability to keep Crohn’s patients in remission in clinical trials, and because it works by a different mechanism than the other drugs.
The multiple sclerosis remedy was pulled from the market after being linked to a rare brain infection. But regulators have allowed renewed sales and, on Dec. 15, Biogen Idec said it was seeking FDA approval to sell the drug as a treatment for moderately to severely active Crohn’s disease.
Jennifer M. Chao , a senior biotechnology analyst at Deutsche Bank , however, maintains a forecast of no revenue from its future use as a Crohn’s therapy.
“Tysabri is much more of a long shot, at this point,” Cheifetz agreed.
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