On April 3, 2017, Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) in Israel announced that the U.S. Food and Drug Administration (FDA) has approved AUSTEDO™ (deutetrabenazine) tablets for the treatment of chorea associated with Huntington’s disease (HD). Teva is the world’s largest generic medicines producer. Previously referred to by the developmental name SD-809, AUSTEDOTM is the first deuterated product approved by the FDA and only the second product approved in HD. The product was previously granted Orphan Drug Designation by the FDA. A rare and fatal neurodegenerative disorder, HD affects more than 35,000 people in the United States. Chorea – involuntary, random, and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of this disease and occurs in approximately 90% of patients. “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 Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “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.” The FDA approval was based on results from a Phase III randomized, placebo-controlled study to assess the safety and efficacy of AUSTEDO™ in reducing chorea in patients with HD (First-HD). “At Teva, we have a long history of establishing comprehensive disease management programs in chronic disease areas.
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