Posted from: Thursday, May 04, 2017 - 04:28 PM - Present

Austedo Approved for Chorea Associated with Huntington

April 3, 2017 – The U.S. FDA approved Austedo™ (deutetrabenazine) for the treatment of chorea associated with Huntington’s disease (HD). Austedo is manufactured by Teva. The recommended starting dose is 6mg once daily. The dose should be titrated up at weekly intervals by 6mg per day to a maximum dose of 24mg twice daily. Total daily doses of 12mg or above should be divided into two doses. Teva plans on launching Austedo by April 25, 2017 and the wholesale acquisition cost is estimated to be $60,000 per year. It will be available through a limited network of specialty pharmacies.

Austedo is a vesicular monoamine transporter 2 (VMAT2) inhibitor and will compete with Xenazine® (tetrabenazine) manufactured by Valeant Pharmaceuticals. Xenazine is another VMAT2 inhibitor and has been the only drug approved for HD since 2008. Xenazine is dosed three times daily compared to twice daily for Austedo. Similar to Xenazine, the labeling for Austedo contains a boxed warning concerning the risk of depression and suicidality. However, the risk of depression and suicidality is lower with Austedo compared to Xenazine.

Austedo is also expected to receive an expanded indication to treat tardive dyskinesia by Aug. 30, 2017 and will compete with Ingrezza.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

 

Last Updated Wednesday, July 26, 2017 - 10:42 PM.