August 16, 2005

The expected U.S. launch of Teva Pharmaceutical's new Parkinson's disease drug Agilect was delayed for a second time after the FDA informed the company it still has concerns about the firm's new drug application (NDA) for the product.

The FDA reiterated its position that the application for Agilect (rasagiline mesylate) is approvable, Teva said recently.

However, "there remain a number of issues that Teva believed it had resolved with its submissions, but as to which the FDA continues to have concerns," the firm added.

"The FDA has indicated its interest in a follow-up meeting to discuss issues raised in the letter," the drugmaker said. "Teva intends to meet promptly with the FDA and to work closely with the agency to resolve these issues." Teva did not disclose the nature of the FDA's latest concerns with the application.

This is the second delay to the Agilect application. The FDA had initially set a May 4 deadline to review Agilect, but agency officials told the firm May 3 that they required an additional three months 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 market for Parkinson's drugs is estimated at roughly $2 billion annually. Agilect is the second brand drug that Teva, the world's largest generic firm, has brought to market. Its other brand product, the multiple sclerosis drug Copaxone (glatiramer acetate), generated sales of $291 million in the second quarter.