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FDA approves Teva's Huntington's disease drug at second attempt

Austedo will treat fatal degenerative disorder chorea

TevaThe FDA approved Teva's treatment for symptoms associated with Huntington's disease (HD) yesterday, ending a decade-long drought in new therapies for the neurodegenerative disease.

The US regulator has approved Austedo (deutetrabenazine) for the treatment of chorea associated with HD, the involuntary twisting and writhing movements that are one of the most characteristic features of the disease, after turning it down last year with a request for more data.

The green light gives patients with HD in the US the first alternative to Lundbeck's already approved Xenazine (tetrabenazine) drug, which was launched onto the market in 2008. Sales of Xenazine slid by almost a third last year to $225m thanks to the start of generic competition towards the end of 2015.

Teva thinks Austedo offers improved safety and efficacy that should encourage uptake, estimating that because of a high dosing frequency (up to three times a day) and side effects such as sleepiness and nausea, only 5% of eligible patients are actually treated with Lundbeck's drug.

The FDA approval is based on the results of a phase III trial called First-HD, which showed that deutetrabenazine reduced chorea symptoms significantly more than placebo with some benefits - such as improved swallowing - that have not been reported in studies of tetrabenazine.

The study was placebo-controlled however, so a more comprehensive view of whether the new drug is better will depend on the outcome of the ongoing ARC-HD trial, which is looking at symptom control in patients who switch to Teva's drug from tetrabenazine. Results from that trial are due later this year.

"Chorea is a major symptom for many living with Huntington disease," said Teva's chief scientific officer Michael Hayden. "It impacts patients' functionality and activities of daily living, and there have been limited treatment options for these patients."

The approval in HD is an important step forward for deutetrabenazine, but for Teva the big return on its investment in the drug could come if it can get approval for tardive dyskinesia, a much larger movement disorder indication, which has no approved therapies in the US.

It is estimated that around 35,000 people have HD in the US, but the population with tardive dyskinesia, which often develops as a complication of psychoactive drugs used to treat mental illnesses such as schizophrenia and bipolar disease and the gastrointestinal therapy metoclopramide, is around half a million.

Deutetrabenazine was acquired by Teva when it bought Auspex Pharma for $3.5bn in March 2015.

Article by
Phil Taylor

4th April 2017

From: Regulatory



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