The new once-daily formulation of Austedo is used to treat adults with tardive dyskinesia and chorea associated with Huntington’s disease.
The FDA has approved an extended-release version of Teva Pharmaceuticals’ Austedo (deutetrabenazine), a new once-daily formulation to treat adults with tardive dyskinesia (TD) and chorea associated with Huntington’s disease (HD).
Tardive dyskinesia is a chronic movement disorder that affects one in four people who take certain mental health treatments. It is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts. Huntington’s disease is a fatal neurodegenerative disease. Chorea – involuntary, random and sudden, twisting and/or writhing movements – is one of the most striking physical manifestations of Huntington’s disease and occurs in about 90% of patients.
“For some patients living with TD and HD, treatment adherence can be a challenge that this new once-daily dosing option can help to address,” Eric Hughes, M.D., Ph.D., executive vice president of R&D and chief medical officer at Teva, said in a press release.
Austedo XR has been shown to be therapeutically equivalent to the twice-daily formulation, providing another effective treatment choice. It will be available in three tablet strengths – 6 mg, 12 mg, and 24 mg. The extended-release version will be available later this year.
Teva officials didn’t respond requests for a list price of Austedo XR. The twice-daily Austedo has an average retail price of $6,039 for 60 tablets, according to GoodRx.
In October 2022, Teva published data from a three-year, open-label study of long-term treatment with the twice-daily Austedo in 119 patients with chorea. Exposure-adjusted incidence rates (EAIRs) were used to compare the frequency of adverse events (AEs) in this long-term open-label extension study. The study included 82 patients who completed the placebo-controlled First-HD trial, and 37 patients who converted from a stable tetrabenazine dose to Austedo.
Exposure-adjusted incidence rates were used to compare the frequency of adverse events (AEs) in this extension study with those in the short-term First-HD study. Common adverse events in the rollover and switch cohorts included: fall, depression, anxiety, insomnia, somnolence, and akathisia. There were no new safety concerns.
AstraZeneca, Daiichi Sankyo Submit New BLA for Datopotamab in Lung Cancer
November 12th 2024After feedback from the FDA, the companies have voluntarily withdrawn the previous biologics licensing application for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous non-small cell lung cancer.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
Skyrizi Overtakes Humira in U.S. Sales Numbers
November 8th 2024For the first time, Skyrizi has replaced Humira as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
Read More