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Teva’s drug Austedo gains FDA approval for chorea linked with Huntington's disease

Apr 05, 2017

Teva’s drug Austedo gains FDA approval for chorea linked with Huntington's disease

Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has Okayed Austedo™(deutetrabenazine) drug tablets for treating chorea consorted with Huntington’s disease (HD), thereby giving patients the first novel treatment option in almost a decade.

 

The company also noticed that the drug, also termed as SD-809, is the second medicine approved in HD, and the first deuterated product cleared by the agency.

 

Huntington’s disease is a rare and fatal neurodegenerative disorder that affects over 35,000 people in the United States. Chorea, which is a sudden and random involuntary twisting or writhing movements, is a vital physical indication of this disease prevailing in nearly 90 percent of the patients.

 

The FDA had given this product an Orphan Drug Destination earlier.

Michael Hayden, M.D., Ph.D., Chief Scientific Officer at Teva and President of Global R&D said: “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

He feels exclusively positioned to get this specific treatment option forward owing to the fact that outcomes depicted in the clinical program backed the approval of Austedo and their enduring extreme commitment to patients.

The drug – Austedo, SD-809 is an oral, untried small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, which is made to stimulate the levels of a particular neurotransmitter, dopamine, in the brain.

Teva’s untried drug bettered the total highest Chorea scores for patients in the clinical trials by nearly 4.4 units from baseline up till the maintenance period, i.e., mean of weak 9 and weak 12, in comparison with estimate 1.9 units in the placebo arm.

Louise Vetter who is the chief executive of the Huntington’s disease society in America says that Chorea linked with Huntington’s disease has a substantial effect on those who have been living with the disease and also their families.

He says: “The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community.”

The medication drug, which was apprehended by Teva through its buy of Auspex and is presently the primarydeuteratedelement to be affirmed by the FDA, is likewise as of now under a need assessment for the uncommon hyperkinetic movement disorder tardive dyskinesia.

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