Teva’s Huntington’s treatment becomes first FDA-approved deuterated drug
pharmafile | April 4, 2017 | News story | Manufacturing and Production, Sales and Marketing | Austedo, FDA, Teva
Israel’s Teva Pharmaceuticals has announced that the FDA has given its approval for Austedo (deutetrabenazine) in the treatment of chorea arising from Huntington’s disease.
The drug was originally knocked back last year due to concerns over metabolites within patients following treatment. The decision marks the first FDA approval for deuterated drugs, a class of treatments which cause therapies to break down and act more slowly on patients, allowing a lower dose to have a more potent effect.
Austedo, a small molecule inhibitor of vesicular monoamine 2 transporter, functions by regulating dopamine levels in the brain. Teva picked up the therapy when it acquired Auspex in 2015.
Chorea refers to the involuntary writhing movements which affect up to nine out of ten Huntington’s patients, as a result of the breakdown of the brain’s nerve cells caused by the disease.
“Chorea is a major symptom for many living with Huntington disease. It impacts patients’ functionality and activities of daily living, and there have been limited treatment options for these patients,” said Teva CSO Michael Hayden. “Based on the results demonstrated in the clinical development program which supported the approval of Austedo and our ongoing commitment to patients, we feel uniquely positioned to bring this treatment option forward.”
Analysts foresee up to $850 million in sales for the treatment by 2023.
Matt Fellows
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