FDA Approves Austedo Tablets to Treat Movement Problems in Huntington’s
Teva Pharmaceutical Industries‘ Austedo tablets have received U.S. approval for treating chorea, or severe movement problems, associated with Huntington’s disease (HD).
Austedo (deutetrabenazine, SD-809) is the first deuterated drug the U.S. Food and Drug Administration (FDA) has authorized, and only the second therapy it has approved for Huntington’s. The FDA had previously granted Orphan Drug Designation to Austedo. A deuterated drug is one in which deuterium has replaced one or more of the therapy molecule’s hydrogen atoms.
Chorea covers movements that are abnormal, involuntary, brief, abrupt, irregular, and unpredictable. It is one of the most marked physical manifestations of Huntington’s, occurring in about 90 percent of patients.
“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,” Rob Koremans, MD, president and CEO of the Global Specialty Medicines division at Teva, said in a press release. “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.”
The drug’s approval was delayed when the FDA asked Teva to examine the blood levels of certain metabolites in patients who took it. The agency did not ask for additional clinical trials, however.
The FDA’s approval was based on results of the First-HD Phase 3 clinical trial (NCT01795859), which included 90 patients. It showed that Austedo improved chorea in Huntington’s patients.
The average scores of the patients who took the drug improved by 4.4 points on an index known as the Total Maximal Chorea Score. Patients who got a placebo showed only a 1.9-point improvement. Those in the trial had scores of 8 or higher before treatment.
The results were published in the journal JAMA in July 2016 under the title “Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease,”
Huntington’s is a rare and fatal neurodegenerative disorder. About 30,000 Americans have it, but more than 200,000 are at risk of inheriting it, according to the Huntington’s Disease Society of America.
“Chorea is a major symptom for many living with Huntington disease. It impacts patients’ functionality and activities of daily living, and there have been limited treatment options for these patients,” said Michael Hayden, MD, PhD, the president of global research and development and chief scientific officer at Teva. “Based on the results demonstrated in the clinical development program which supported the approval of AUSTEDO™ and our ongoing commitment to patients, we feel uniquely positioned to bring this treatment option forward.”