Azilect already has approval by the FDA to treat symptoms of the neurological disorder (such as shaking, stiffness, impaired balance). However, Teva are now seeking an extension of Azilect’s label. However, it is being scrutinized by the FDA as they question it’s effectiveness in slowing down the progression of the disease.
Scepticism regarding the drug stems from results from Teva’s latest trial – the disease appeared to deteriorate more slowly in patients who started taking the drug early in the progression of the disease, rather than later. However, whilst the 1mg dose slowed progression, the 2mg dose did not. This has brought questions about the trial results.
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