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Weighing a New Pill that Treats MS

September 30 2010 | by

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Lenore Cameron has her rituals. Up before the sun, she’s at her desk by 6:00 every morning. She toggles between her job and her two teenage sons. And she gives herself regular injections to treat multiple sclerosis, a chronic nervous system disease that sometimes cripples her ability to juggle home and work.

“I couldn’t get myself wrapped around it,” Cameron says of her 2007 diagnosis. “But now, it’s all about figuring out how to best handle it.”

So far, Cameron has handled her MS with weekly injections. Along the way, she has struggled with some severe side effects -– from fever and hives to anaphylaxis, a life-threatening allergic reaction that requires emergency medical treatment. She has also had to face her fear of never knowing which batch of medication would hit her hard.

“I may have an allergic reaction to all the injections in a particular batch –- or I may have no reaction to any of them at all,” says Cameron, who works as the executive director of Little Hearts, a nonprofit that provides support to families affected by congenital heart defects. “I’m playing Russian Roulette every time I open the box [of drugs].”

Game over
If Novartis has its way, millions of MS patients like Cameron will never have to gamble like that again. The U.S. Food and Drug Administration last week approved the company’s new MS drug, Gilenya – the first pill to treat MS. Novartis’ new oral treatment has been shown to significantly reduce relapses and delay progression of MS in clinical trials.

Gilenya stands to help countless patients. About 2.1 million people have MS worldwide – with more than 400,000 in the United States alone, according to the National Multiple Sclerosis Society. Overall, this is great news for this population. But what about the risks?

The good and the bad
Multiple sclerosis causes the body’s immune system to attack the protective coatings of the brain and spinal cord. Gilenya works to reduce a type of white blood cell that tends to attack the nervous system, helping to reduce MS progression and relapses, or flare-ups. But the drug comes with potential side effects and FDA warnings.

Forbes Magazine reported that initially, Gilenya had the potential to have so many horrible side effects that it could have been held up in the FDA approval process. However, it pushed through, partly because Novartis lowered the dose used in trials — and still found it highly effective.

Side effects include possible lung, heart and eye toxicity and increased risk for infection. Overall, Gilenya’s benefits outweighed the risks among the 2,600-plus MS patients who took the pill in clinical trials.

What’s next
The FDA panel that approved Gilenya recommends that patients receive their first dose of the drug under doctor supervision, and that they also get eye exams to screen for potential side effects. The drug also may have to be on the market a while before some doctors are comfortable prescribing it to patients.

But for Novartis, time is of the essence. While Wall Street analysts expect Gilenya’s annual sales to top $1 billion, the competition may not be too far behind. Sanofi-Aventis and Biogen Idec have rival MS pills in clinical trials, and Merck expects to hear from the FDA about its own late-stage MS oral treatment –- cladribine -– before the end of the year.

For patients like Cameron, Gilenya could be a game changer. “If I could take this pill and not have any allergic reactions -– and not have any of the side effects they mention on the warning label, it would be a piece of cake,” she says. “It would be one less thing I have to handle. One less medication to take. One less worry. If this could work, I’d be thrilled.”

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