Teva Gets Parkinson's Drug OK

Azilect was approved in Europe and Israel in 2005, and is available in 13 European Union countries, where Teva collaborates in marketing with the Danish drug company Lundbeck.

Azilect was developed by Teva based on research from the Technion Israel Institute of Technology. The drug was known as Agilect while it was being developed in the U.S., where Teva will handle the marketing. Teva said it is waiting to hear whether Japan's Eisai will co-promote the drug in the U.S. Since 2003, Teva and Eisai have been testing Azilect as a treatment for Alzheimer's disease.

Azilect took a number of regulatory detours before reaching the U.S market. Teva submitted its original application in September 2003, and the FDA granted conditional approval in July 2004. Teva filed answers to FDA's questions, but the agency told Teva in August that it was delaying a final decision because certain issues needed to be resolved.

The company warns patients to avoid eating foods, drinking beverages and taking dietary supplements that contain tyramine. Because it is a monoamine oxidase inhibitor, Azilect affects the body's ability to process tyramine, an amino acid that regulates blood pressure. Certain foods -- such as red wine, smoked or cured meats, many cheeses and saukerkraut -- raise tyramine levels, creating a dangerous spike in blood pressure.

The company also is warning patients about taking the medication with other prescription drugs. "It seems prudent, in general, to avoid the combination of Azilect with antidepressants," Teva says. It adds that patients should avoid additional types of medications, ranging from other monoamine oxidase inhibitors to methadone, as well as St. John's Wort and certain over-the-counter cold remedies.

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