FDA Advisory Panel Says Azilect Not Effective to Delay Parkinson’s Disease

A Food and Drug Administration advisory panel Oct. 17 voted unanimously that Teva Pharmaceutical Industries Ltd. has not provided enough evidence to prove that Azilect (rasagiline) is effective as a treatment to delay clinical disease progression in patients with Parkinson’s disease.

The Peripheral and Central Nervous System Drugs Advisory Committee voted 17-0 that Teva has not provided substantial evidence of effectiveness for Azilect in this indication, an FDA spokeswoman told BNA Oct. 18.

Azilect already is approved by FDA for treating the signs and symptoms of idiopathic Parkinson’s disease as initial therapy alone and to be added to levodopa later ...