Teva's Agilect Launch Delayed Over Extended FDA Review

Teva Pharmaceutical's U.S. launch of its new Parkinson's disease treatment Agilect has been delayed by up to three months after the FDA elected to extend the drug's review period.

The FDA had initially set a May 4 deadline to review Teva's new drug application (NDA) for Agilect (rasagiline mesylate), but agency officials recently informed the company that an additional three months were required to review recently submitted data about the drug. Teva submitted the new data to clarify a technical error that the FDA found in Agilect's original NDA.

"The FDA has informed us that because of this late submission, it is going to extend its review time by up to another three months," George Barrett, president and CEO of Teva North America, said during a conference call to discuss the company's first-quarter earnings.

Teva's Agilect launches are proceeding more smoothly in other countries, including Israel, where the drug was launched in March. The company plans to launch Agilect in Europe beginning in mid-2005, said Barrett, who noted Germany and the UK will be the first targets for the European launch.