Kari Antin, a 40-year-old financial analyst in Minneapolis, knows shes taking a life-or-death risk with every monthly infusion of Biogen (BIIB) Idec Inc.s Tysabri.
She is among the 55 percent of multiple sclerosis patients who harbor a potentially lethal virus that can be reactivated by the drug, allowing it to creep from the kidneys to the brain, where it destroys cells that protect the nerves. The risk soars after two years of treatment. Still, Antin insists on sticking with the drug she credits with restoring her health.
Its a dilemma faced by almost 60,000 multiple sclerosis patients worldwide who continued on Tysabri beyond the recommended two years. Its also new territory for Biogen, as the number of patients pushing the time limit increases, and a concern for prescribing doctors who increasingly find patients resolute about staying on the potent medicine that reduces the risk of relapse by 68 percent.
I dread the thought of being in a wheelchair, said Antin, who has had only one relapse on Tysabri and just returned from sailing a 50-foot catamaran with a group of friends in the British Virgin Islands. If the alternative is that I die, I would rather that than lose the quality of life. To me, it all comes down to personal choice and what youre willing to risk.
Tysabri is the most effective MS medicine available, generating $1.1 billion annually for Weston, Massachusetts-based Biogen. The company dominates the market for MS and its latest treatment, Tecfidera, has helped push up the companys shares 32 percent since its March approval. Thats outpaced the 16 percent increase in the Nasdaq Biotechnology Index and the 5.9 percent gain in the Standard & Poors 500 Index. (SPX) They advanced less than 1 percent to $233.07 at the close of trading in New York yesterday.
While Tecfidera has shown none of the same risks of Tysabri, it may also not control the disease as well. Yet with Tysabris greater efficacy comes the chance of disability or death caused by a brain infection. The two-year warning was added to the drugs prescribing label in 2011.
More than 2.1 million people worldwide have multiple sclerosis. The chronic disease develops when a persons immune system inexplicably attacks the brain, spinal cord or optic nerves. Symptoms range from mild numbness or loss of coordination to paralysis and blindness. The most common form is marked by terrifying relapses were symptoms surge, followed by quiet periods of remission. There is no cure.
The goal of treatment is to stop the relentless descent into disability.
Thats something only the patient can understand, said Al Sandrock, Biogens chief medical officer. They knew what it was like before they were on Tysabri, and how they did on the drug. We dont have any good ways of repairing the brain right now. All we can do is prevent MS lesions from forming and Tysabri is very good for that.
Uncertainty has surrounded Tysabri since its beginning. The drug was pulled off the market after just three months of sales in 2005 when three patients developed the brain disorder, called progressive multifocal leukoencephalopathy. Two of the three subsequently died. The drugs effectiveness, however, drew passionate appeals from patients and doctors that led regulators to allow sales to resume the following year with strict rules governing its use.
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