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Neurocrine bags FDA approval for first tardive dyskinesia drug

Ingrezza edges ahead of Teva’s rival drug Austedo


Neurocrine Biosciences has claimed the distinction of getting the first-ever FDA approval for a drug to treat tardive dyskinesia, a movement disorder affecting around 500,000 people in the US.

The regulator approved VMAT2 inhibitor Ingrezza (valbenazine; NBI-98854) to treat adults with tardive dyskinesia, a neurological disorder characterised by repetitive involuntary movements such as grimacing, sticking out the tongue and smacking the lips.

It is most commonly seen as a side effect of certain medicines used to treat psychoses such as schizophrenia, bipolar disease and the gastrointestinal therapy metoclopramide, and given the high number of sufferers, analysts predict the market for an effective treatment could top $2bn a year.

With the FDA green light Neurocrine has nosed ahead of Teva in the race to bring a VMAT2 inhibitor to market for tardive dyskinesia, although its Israeli rival has just claimed US approval for Austedo (deutetrabenazine) for movement symptoms associated with Huntington's disease, with a much smaller patient population.

Teva reported positive phase III data for Austedo in tardive dyskinesia last year and filed for US approval last month, so Neurocrine should have a few months grace with its new drug before it has competition in the market.

Ingrezza's approval is based on the results of a clinical trial involving 234 patients that compared Ingrezza to placebo. After six weeks those on Neurocrine's drug - which has breakthrough status from the FDA - showed improvement in the severity of abnormal involuntary movements compared to those on control.

The company has been adding to its salesforce in anticipation of the new approval, with the aim of recruiting 140 reps to detail Ingrezza six weeks post-approval.

Neurocrine says it is also expecting to report results for a trial of valbenazine in children with Tourette's syndrome next month, although an earlier study in adults failed to show a statistically significant impact on symptoms such as tics but did indicate a trend towards improvement. If positive, Neurocrine is hoping to start a phase III trial in paediatric Tourette's in the latter half of the year.

The company fleshed out its movement disorder pipeline earlier this year by licensing opicapone from Portuguese drug maker BIAL. The COMT inhibitor was approved in Europe as Ongentys last June as an adjunct to Parkinson's disease treatment, and Neurocrine is hoping to meet with the FDA to see what would be required for a regulatory submission in the US.

Article by
Phil Taylor

12th April 2017

From: Research



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