Regulatory Affairs

FDA approves Teva’s austedo to treat chorea in HD patients

PBR Staff Writer Published 04 April 2017

Teva Pharmaceutical has secured approval from the US Food and Drug Administration (FDA) for austedo (deutetrabenazine) tablets to treat chorea associated with Huntington’s disease (HD).

Formerly known under the developmental name SD-809, austedo has now become the first deuterated product to get FDA approval and also the second drug approved in HD.

Previously designated as an orphan drug, austedo’s FDA approval was based on the findings of a late-stage study which assessed its safety and efficacy in decreasing the intensity of chorea in HD patients.

Teva global specialty medicines president and CEO Rob Koremans said: “At Teva, we have a long history of establishing comprehensive disease management programs in chronic disease areas. We have highly skilled teams experienced in building relationships with patients, their care partners and healthcare professionals.

“Bringing a new treatment forward where the unmet need is so significant is an inspiring opportunity. Our commercial and medical organizations are well prepared to make this important treatment available to the HD community.”

Austedo’s efficacy was established in a randomized, double-blind, placebo-controlled phase 3 trial held at multiple centers and featuring 90 ambulatory HD patients having chorea.

Huntington’s Disease Society of America CEO Louise Vetter said: “Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families.

“The FDA’s approval of Austedo represents an important new treatment option for people with HD and highlights the need for more therapeutic resources for this underserved patient community.”

As per the trial findings, the total maximal chorea scores for patients treated with austedo grew by nearly 4.4 points from baseline to the maintenance period. The placebo group on the other arm could only score 1.9 units in comparison with the trial yielding a statistically important difference of -2.5 units.

A week after stopping the study medication, the total maximal chorea scores among the austedo patient arm had returned to baseline.