FDA approves first and only tardive dyskinesia treatment

pharmafile | April 12, 2017 | News story | Research and Development, Sales and Marketing FDA, Neurocrine Biosciences, tardive dyskinesia 

US patients suffering with tardive dyskinesia (TD) will see access to the first approved treatment in the country with the news that the FDA has given the go-ahead for Neurocrine Biosciences’ Ingrezza (valbenazine).

TD is a neurological condition affecting more than 500,000 people in the US and is characterised by repetitive involuntary movements of the extremities or face. It is often a side-effect of antipsychotic treatments which block the brain’s dopamine receptors, causing irregular signalling in the part of the brain which governs movement. The symptoms are often severe and can be irreversible.

Ingrezza is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor which reduces the amount of dopamine in this region of the brain, regulating nerve signalling and restoring natural movement. In a Phase 3 trial, the drug met its primary endpoint, with 40% of patients taking 80mg a day achieving at least a 50% reduction in AIMS dyskinesia score, compared to just 8.7% for placebo.

“The often debilitating effects of tardive dyskinesia have left people feeling isolated and forgotten. The approval of Ingrezza represents a turning point for these patients and their care partners, offering a meaningful treatment where before there was little hope,” said Kevin C. Gorman, Chief Executive Officer of Neurocrine Biosciences. “For the past 20 years, Neurocrine has been devoted to developing treatments for difficult to manage conditions in underserved patient populations. We are committed to ensuring that those impacted by the disruptive effects of TD have access to Ingrezza.”

The drug is to be made available through select pharmacies next week, with promotion to healthcare professionals beginning on 1 May.

Matt Fellows

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