FDA Approves New Treatment Application for Huntington Disease

Drug reduced chorea and writhing movements in patients afflicted with the disease.

Drug reduced chorea and writhing movements in patients afflicted with the disease.

Teva Pharmaceutical Industries announced that a New Drug Application (NDA) for deutetrabenazine (SD-809) has been approved by the FDA for the treatment of chorea associated with Huntington disease (HD).

HD is a rare and fatal neurodegenerative disorder caused by the breakdown of nerve cells over time in the brain. The disease affects about 5 to 7 people per 100,000 in western countries, according to the World Health Organization.

Teva announced the approval of the drug following clinical studies that yielded positive results regarding safety profile and tolerability profile. The NDA filing is based off of the findings from a pair of phase 3 studies, FIRST-HD and ARC-HD. The placebo group in the FIRST-HD study demonstrated that SD-809 reduced chorea and writhing movements associated with HD. The ARC-HD study showed that patients were able to safely convert from tetrabenazine to SD-809 overnight with continued control of chorea.

“Teva plans to commercialize SD-809 in the US by drawing from vast experience in facilitating therapy initiation and patient support in other disease areas. Within Global Specialty Medicines, we have a rich history of demonstrating our commitment to the patient and bringing value to the neurology community,” Rob Koremans, MD, president and chief executive officer of Global Specialty Medicines at Teva, said in a press release. “People living with neurodegenerative disorders and those around them often need support and services beyond medications. We intend to meet these needs with our proven infrastructure and our focus on the patient.”

Teva added SD-809 to their portfolio following the takeover of Auspex in May 2015, according to the press release. SD-809 was granted Orphan Drug Designation for the treatment of HD in November 2014.

The new drug brings about an optimal alternative to HD patients who previously were only treated with tetrabenazine. Reducing incidence of of chorea in HD patients, SD-809 will provide relief to many HD patients suffering from involuntary spasms.