(dailyRx)
A U.S. Food and Drug Administration panel has unanimously voted to reject an expanded indication for Parkinson’s drug rasagiline (Azilect).
The drug already was FDA approved for treating the signs and symptoms of Parkinson’s disease, but drug maker Teva Pharmaceutical Industries, Ltd. had requested a label change stating that the medication slows the clinical progression of Parkinson’s disease.
The panel was not convinced that Teva’s latest clinical trials proved that the drug can successfully slow progression of the neurodegenerative disease. No drug has yet been approved to receive such a label.
Azilect currently is on the market for symptoms related to Parkinson’s disease including stiffness, impaired balance, trembling limbs and slow movement.
In a joint statement, community Parkinson’s organizations including the American Parkinson Disease Association, The
Michael J. Fox Foundation for Parkinson’s Research, the National Parkinson Foundation, the Parkinson’s Action Network, the Parkinson Alliance, and the Parkinson’s Disease Foundation. urged rigorous evaluation.
In the statement the groups said: “While we are encouraged by the evidence presented to date, it appears to our community that the data surrounding Azilect as a therapy that slows clinical progression of Parkinson’s are not yet definitive, and that additional information is required to completely determine the impact of Azilect on clinical disease progression.”
The National Institutes of Health estimate that half a million people in the United States suffer from Parkinson’s disease, and other estimates state that figure may be much higher. Parkinson’s disease is a neurodegenerative disorder that results from the death of neurons in a part of the brain called the substantia nigra, the cells that make the neurotransmitter dopamine.
The primary symptoms are a resting tremor (disappears when a patient goes to make a movement), rigidity (stiffness of muscles), bradykinesia (slowness of movment, often seen as a shuffling walk), and unstable posture which leads to frequent falls. As the disease progresses, patients often experience dementia, with changes in mood, cognition, behavior, and thoughts. Depression and anxiety are also common, and psychosis has been seen in late PD. Diagnosis is made from symptoms and neurological exams, but there is no lab test that will clearly identify the disease. If symptoms improve when patients are given drugs to treat Parkinson’s disease, the diagnosis is usually confirmed.