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FDA approves first oral drug to modify MS course

The U.S. Food and Drug Administration on Wednesday approved the first oral disease-modifying drug for multiple sclerosis, making an appealing new treatment option available to hundreds of thousands of people with a common form of the disease.

Fingolimod capsules, to be marketed as Gilenya by drug-maker Novartis International AG, have been shown to reduce the incidence of MS symptoms and slow development of physical disability among people with relapsing MS. Novartis says the drug will be available for prescription in coming weeks.

The capsule may prove a boon to people who shy away from needles; existing MS disease-modifying therapies are administered by injection or intravenously. It's unclear yet how much the drug will cost and what the insurance coverage scene will be. But people can be prescribed Gilenya without having to try other treatments first. Compliance with treatment plans is a big issue in MS; many people don't believe the benefits of existing drugs outweigh the hassle of the injections.

Still, it's unclear how many people currently using injectable MS treatments will switch to the new oral drug. Patients are advised to talk with their doctors about that. For many, the potential and serious side effects -- including increased risk of infection and toxicity to the eyes, liver, lungs and heart -- may encourage continuing with their needle-injected drugs, most of which are free of serious side effects.

Me? I'm planning to stick with my daily shot, which seems to have served me well for the nine-plus years I've been on it. I'm so used to the bruises and funky indentations in my skin that come after years of poking myself, I'm in no hurry to change. But I'm really happy for the people who might seek treatment, now that no needle's needed. And I'm really happy to see the fight against MS continue. Maybe one day soon there'll be a cure.

By Jennifer LaRue Huget  | September 23, 2010; 7:00 AM ET
Categories:  Multiple Sclerosis, Neurological disorders  
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