Teva Pharmaceuticals' Parkinson's disease drug Azilect may not win approval from the Food and Drug Administration, after the agency expressed doubts Thursday about its effectiveness, The Associated Press reported.
Teva studied the drug in 1,176 patients with very early Parkinson's disease who had not received any other treatment. A 1-mg dose of the drug, known generically as rasagiline, appeared to slow the progression of the disease in trial patients. The 2-mg dose, however, did not show similar results. Study results also showed disparate effects between men and women and uneven side effects.
"The failure of the 2 mg group raises serious questions about the interpretation of this study, and, therefore, about whether or not rasagiline has been shown to have disease-modifying effects," FDA reviewers wrote in an online document. "There is no obvious biological explanation for why the 2 mg dose should not be disease-modifying, if the 1 mg dose is."
Azilect is already approved to treat Parkinson's symptoms. The FDA however, may not approve it to slow the progression of the disease, as Teva had requested. No drug is currently on the market to slow Parkinson's, which affects about 5 million people worldwide, and 1.5 million in the U.S. The disease affects brain cells that produce dopamine, the chemical that controls muscle movement, and leads to tremors and frozen limbs. Current treatments include dopamine-boosting medication and implanted deep brain stimulation.
A panel of outside experts will rule Monday whether Teva's studies have proved Azilect's effectiness in slowing the course of Parkinson's, though the FDA is not necessarily required to abide by the decision.
