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FDA advisers skeptical on Teva Parkinson's drug
Advisers to the Food and Drug Administration, following the note struck by FDA researchers last week, voted unanimously to say that data from Teva’s latest trial were unconvincing of Azilect’s ability to delay the clinical progression of Parkinson’s.Azilect, generically known as rasagiline and already approved as a Parkinson’s therapy, is the first drug to seek FDA’s approval as a medicine that affects the course of the neurogenetic disorder instead of merely masking its symptoms.”This is really going to be the flagship… and we have to be very solid in this and set a very high standard,” said Dr. Robert Clancy, one of the panel members and a neurology professor at the Children’s Hospital of Philadelphia.”If we’re wishy-washy with this, then the next thing that comes around is going to be expecting that being close is good enough. And this is close, but it’s not good enough.”Azilect, which Israel-based Teva markets alongside Danish partner Lundbeck in several countries, already has FDA approval to treat symptoms of the neurological disorder, such as trembling limbs, stiffness, slow movement and impaired balance. Teva is seeking an expansion of Azilect’s label.In Teva’s latest trial, Parkinson’s appeared to deteriorate more slowly in patients who started taking Azilect earlier than in those who began later. But while the 1 milligram (mg) dose appeared to slow the progression, the 2 mg dose did not, overshadowing the results of the 1 mg trial under review.