Teva Finally Wins FDA Approval for Potential Huntington’s Blockbuster Austedo

April 4, 2017
By Alex Keown, BioSpace.com Breaking News Staff

JERUSALEM – Israel-based Teva Pharmaceuticals finally won approval from the U.S. Food and Drug Administration (FDA) for Austedo, a treatment for chorea associated with Huntington’s disease, the company announced Monday.

Austedo (deutetrabenazine), formerly known as SD-809, is the first deuterated product approved by the FDA and only the second product approved for Huntington’s disease, the company said. The drug’s approval was delayed after the company received a Complete Response Letter from the FDA in May 2016. The FDA asked Teva to examine blood levels of certain metabolites. At the time Teva, the world’s largest generic drugmaker, said the metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine. The FDA did not ask for additional clinical trials.

Huntington’s disease is an inherited rare and fatal neurodegenerative disorder that affects more than 35,000 people in the United States. Chorea, which is the involuntary and sudden twisting movements associated with the disease, occurs in about 90 percent of HD patients. Michael Hayden, president of global R&D and chief scientific officer at Teva, said in a statement that chorea “impacts patients’ functionality and activities of daily living.” He said there have been few treatment options available for chorea in HD patients.

Austedo, a small-molecule inhibitor of vesicular monoamine 2 (VMAT2), was previously granted Orphan Drug Designation by the FDA. Analysts have projected sales of Austedo to reach $850 million by 2023, according to Reuters. The FDA approval was based on results from a Phase III trial showing the efficacy of reducing chorea in HD patients. Total Maximal Chorea Scores for patients receiving Austedo improved by approximately 4.4 units from baseline to the maintenance period (average of Week 9 and Week 12), compared to approximately 1.9 units in the placebo group, according to Teva. At the Week 13 follow-up visit, one week after discontinuation of the study medication, the Total Maximal Chorea Scores of patients who had received Austedo returned to baseline.

Austedo is also being explored for other treatment options including treatment for tardive dyskinesia, a severe movement disorder. In March, the FDA granted priority review for Austedo for tardive dyskinesia. A ruling is expected in August. Teva is also exploring the use of Austedo in patients with Tourette syndrome. The drug has been granted orphan drug designation for the treatment of TS in the pediatric population.

Shares of Teva rose slightly Monday to $32.87 on news of the FDA’s approval, but have slipped this morning to $32.08 per share.

Teva reported its debt at the end of 2016 was $35.8 billion, which was down nearly $10 billion from the previous year. The company has been considering selling off or spinning off its branded generics business in an effort to reduce debt, according to reports.