The FDA approved Teva Pharmaceutical's AUSTEDO™ (deutetrabenazine; SD-809) for treating chorea associated with Huntington’s disease (HD). The drug is an oral, small-molecule inhibitor of vesicular monoamine 2 transporter (VMAT2).
FDA approval was based on data from a 90-patient, placebo-controlled Phase III FIRST-HD trial, which showed that patients treated using AUSTEDO achieved a 4.4 unit improvement from baseline in their Total Maximal Chorea Score, compared with an approximately 1.9 unit change in the placebo group.
Teva says AUSTEDO is the first deuterated product cleared by the FDA, and only the second drug approved for HD. “At Teva, we have a long history of establishing comprehensive disease management programs in chronic disease areas. “Bringing a new treatment forward where the unmet need is so significant is an inspiring opportunity,” said Rob Koremans, M.D., president and CEO of global specialty medicines at Teva. “Our commercial and medical organizations are well prepared to make this important treatment available to the HD community.”
“Chorea associated with Huntington’s disease has a significant impact on those living with the disease and their families,” added Louise Vetter, CEO at the Huntington’s Disease Society of America. “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.”
Teva’s initial deutetrabenazine NDA for the HD indication was met in May 2016 by a Complete Response Letter from the FDA, which asked the firm to examine blood levels of certain metabolites. No new trials were requested. The resubmitted NDA was accepted in October that year.
Deutetrabenazine is separately undergoing FDA review for the treatment of of tardive dyskinesia. In February, the agency granted the tardive dyskinesia NDA priority review, and set a PDUFA goal date of August 30th. SD-809 has previously been granted breakthrough therapy designation by the FDA for the tardive dyskinesia indication.
Deutetrabenazine is separately in early clinical development for the treatment of Tourette syndrome. The FDA has granted the drug orphan drug designation for the pediatric Tourette syndrome indication.
Within the last few weeks, Teva confirmed it would be cutting an unspecified number of jobs as part of organization-wide streamlining and cost-cutting program.