Isis' ALS Drug Gets Orphan-Drug Status
By Associated Press December 13, 2007
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Biopharmaceutical company Isis Pharmaceuticals Inc. said Thursday the Food and Drug Administration granted the company U.S. market exclusivity for its investigational drug to treat Lou Gehrig's disease.

The drug, ISIS 333611, is designed to treat the nervous-system disease that results in the loss of muscle control and can lead to death.

Isis said the FDA granted its drug candidate orphan-drug status, which entitles the company to seven years of U.S. market exclusivity for ISIS 333611 for the treatment of amytrophic lateral sclerosis. The Orphan Drug Act gives companies economic incentives to encourage the development of drugs for diseases affecting fewer than 200,000 people in the U.S.

ALS, commonly referred to as Lou Gehrig's disease, is diagnosed in a little more than 5,600 people per year in the U.S., according to The ALS Association.

ISIS 333611 is Isis' first drug treating neurodegenerative diseases to enter development.
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