US FDA accepts Teva's NDA for SD-809 for Huntington disease

The New Drug Application for SD-809 (deutetrabenazine) has been accepted by the US Food and Drug Administration, according to the drug’s developer, Israel-based generics giant Teva Pharmaceutical Industries (NYSE: TEVA).

The FDA filing is seeking approval of the drug for the treatment of chorea associated with Huntington disease (HD), a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries, according to the World Health Organization.

“The opportunity to bring a new treatment option to those battling the devastating illness of Huntington disease is an important first step and an indication of our profound commitment to improving the lives of patients with this and other debilitating movement disorders,” said Michael Hayden, president of global R&D and chief scientific officer at Teva, adding: “With this filing and an ongoing investment in HD research, Teva has further established itself as a leader in the development of treatments focusing on movement disorders.”