FDA Accepts Application for Huntington Disease Drug

The FDA could soon approve Teva’s deutetrabenazine (SD-809) for the treatment of chorea associated with Huntington disease (HD), a rare and fatal neurodegenerative disorder.

“The opportunity to bring a new treatment option to those battling the devastating illness of HD is an important first step,” stated Michael Hayden, MD, PhD, president of global R&D and chief scientific officer at Teva.

The New Drug Application for deutetrabenazine is based on positive data from a pair of phase 3 studies. The FIRST-HD trial demonstrated that the drug reduced chorea in HD patients, while the ARC-HD showed that patients were able to safely convert from tetrabenazine—currently the only FDA-approved HD treatment—to deutetrabenazine overnight with continued chorea control.

The FDA granted Orphan Drug Designation to deutetrabenazine in November 2014.

“People living with neurodegenerative disorders and those around them often need support and services beyond medications,” stated Teva president and CEO of global specialty medicines Rob Koremans, MD. “We intend to meet these needs with our proven infrastructure and our focus on the patient.”