- Teva Pharmaceuticals secured approval from the Food and Drug Administration for Austedo (deutetrabenazine), a treatment for chorea due to Huntington’s disease, after a previous rejection last May.
- The spastic movement drug was slapped with a black box warning related to depression and suicidality, but has shown a better tolerability profile for things like sedation, insomnia and fatigue than Lundbeck’s rival Xenazine (tetrabenazine).
- Another company, Neurocrine, is developing a potential competitor, Ingrezza (valbenazine), for tardic dyskinesia and has a target decision date from the FDA of April 11.
Austedo's approval was based on a Phase 3 study that included 90 ambulatory patients with chorea associated with Huntington’s disease. The study showed that the twice daily dosing of Austedo improved symptoms from baseline by 4.4 units, compared with 1.9 units for placebo.
The study also showed that 2% of Austedo patients expressed suicidal ideation, compared with none of the placebo patients, and that 4% of the patient’s on drug showed signs of depression.
Austedo is a deuterated version of Xenazine and has a similar label to the Lundbeck drug. Yet the FDA expressed concerns about the drug building up in tissues, which could result in toxicity.
While Teva said the drug will likely get off to a slow start, analysts from Mizuho expect revenues of $29 million in 2017 and $207 million by 2021.
The Israeli company expects to launch Austedo in the next three weeks and is pricing the drug at a wholesale acquisition cost of approximately $60,000 annually — below that of competition.
Next up for the drug is a pending decision from the FDA on approval for tardive dyskinesia, set for Aug. 30. The company will also be beginning a late-stage trial in Tourette’s syndrome.