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FDA sets August review date for Teva's movement disorder drug

Could be first approved treatment for tardive dyskinesia


Patients with the movement disorder tardive dyskinesia (TD) could have a first approved treatment if the FDA clears Teva's SD-809 candidate later this year. 

The US regulator has granted a six-month priority review to SD-809 (deutetrabenazine) and is due to deliver a verdict on the VMAT2 inhibitor - which has also been given breakthrough status - by 30 August. 

With no approved therapies for TD, analysts have predicted that SD-809 could become a $600m-a-year product by 2020 and achieve blockbuster sales at peak. Teva needs that kind of return, having forked out $3.5bn for SD-809's developer Auspex Pharma in 2015.

TD is characterised by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities, and affects an estimated 500,000 people in the US. It is typically seen as a side effect of drug treatment for schizophrenia and bipolar disease. 

Teva suffered a knockback from the FDA last May for SD-809 when the agency rejected a marketing application for the drug as a treatment for involuntary writhing movements (chorea) associated with Huntington's disease, and asked the Israeli drugmaker to carry out additional testing on metabolites seen after dosing with the drug.

The company submitted the missing data last October and is expecting to hear from the FDA on that application by 3 April. Huntington's disease is a much smaller market than TD but that has not stopped the only approved drug for the condition - Lundbeck's Xenazine (tetrabenazine) - bring in sales of $330m in 2015, although the onset of generic competition cut that back to $230m last year.

SD-809 is a bright spot for Teva, which is currently plagued by a number of problems including pricing erosion in its generics business, competition to big-selling multiple sclerosis drug Copaxone (glatiramer acetate) and disruption among its top management.

The company's main rival in the race to bring a TD drug to market is Neurocrine Biosciences, which has a VMAT2 inhibitor codenamed NBI-98854 in phase III testing. Both companies are also exploring the use of their respective drugs to prevent tics associated with Tourette's syndrome.

Article by
Phil Taylor

1st March 2017

From: Regulatory



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