Amicus to seek earlier-than-expected regulatory approval for its potential Fabry disease drug

Markets Associated Press

Amicus Therapeutics plans to file for accelerated approval of its experimental treatment for a rare, inherited disease following meetings with regulators in the U.S. and Europe.

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Shares of the drug developer jumped more than 30 percent in afternoon trading.

In the U.S., the company plans to file for approval of the drug, called migalastat, with the Food and Drug Administration in the second half of the year, while it plans on asking for approval in Europe during the second quarter. The potential therapy for Fabry disease has already shown positive results in late-stage studies.

Fabry disease is characterized by the buildup of a type of fat in the body's cells and can cause pain, skin problems and kidney and heart problems, among other issues, according to the National Institutes of Health.

The accelerated approval designation allows for drugs aimed at serious conditions to be approved based on less-stringent criteria. The designation is sometimes used by the FDA to review drugs that fill an unmet medical need.

If approved, it would be the first oral treatment for the rare condition. Currently, Genzyme Corp. makes the intravenous treatment Fabrazyme.

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Shares of Cranbury, New Jersey-based Amicus Therapeutics Inc. rose $2.86, or 30.7 percent, to $12.22 in afternoon trading.