Teva’s Austedo is now the first and only therapy approved in the US to treat both tardive dyskinesia and chorea associated with Huntington’s disease.
US regulators have widened the scope of the drug - initially approved for chorea associated with the disease in April 2017 - to include treatment of tardive dyskinesia in adults with the condition.
Tardive dyskinesia is a debilitating movement disorder characterised by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities, affecting around 500,000 people in the US.
Expanded approval of Austedo (deutetrabenazine) was based on clinical trial data showing that the drug provided a significant reduction in tardive dyskinesia, with favourable safety and tolerability.
“We believe physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition,” said Michael Hayden, president of Global R&D and chief scientific officer at Teva.
First Chagras therapy
The Agency also approved Chemo Research’s benznidazole for Chagas disease, or American trypanosomiasis, a parasitic infection caused by Trypanosoma cruzi.
The disease, which primarily affects people living in rural parts of Latin America, can be transmitted through different routes, including contact with the feces of a certain insect, blood transfusions, or from a mother to her child during pregnancy.
After years of infection, the disease can cause serious heart illness, and it also can affect swallowing and digestion.
The FDA cleared benznidazole to treat the disease via its accelerated approval pathway, offering patients the first approved treatment for the disease.