The U.S. Food and Drug Administration has granted approval to Austedo, a drug developed by Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) to treat a condition known as chorea that occurs in the majority of patients suffering from Huntington’s disease. Previously, the drug was referred to by its previous name SD-809.
Chorea patients experience writhing movements that are abnormal and involuntary. This is not always the case but at does happen eventually at some point while they are afflicted with the disease. Huntington’s disease, on the other hand, is inherited and is known to cause nerve cells that are located in the brain to progressively break down. This results in a decline in mental stability, cognition and motor control.
Adulthood symptoms
The symptoms of Huntington’s disease usually appear in adulthood when one is aged between 30 and 50. Once the symptoms appear, they usually worsen in the course of between 10 and 25 years until the patient succumbs to the disease.
The approval of Austedo followed a Phase III study that was placebo-controlled and randomized with a view to testing the efficacy and safety of the drug in the treatment of chorea in those suffering from Huntington’s disease. There were a total of 90 participants in the study, all of whom had chorea as well as Huntington’s disease.
Side effects
Some of the side effects of taking the drug include an increased risk of developing depression as well as suicidal behavior and thoughts. It is therefore recommended that in making the decision of whether to use Austedo or prescribe it, it must be balanced with the risk that comes with it. Consequently, Austedo is not recommended for patients who are considered suicidal. It is also not recommended for patients who are suffering from depression which is yet to be treated or which has been inadequately treated.
Before Austedo, the only other therapy that had been approved by the Food and Drug Administration to treat chorea in patients suffering from Huntington’s disease was Xenazine that was developed by Lundbeck. Austedo is a Zenazine deutenated version.
On Monday shares of Teva Pharmaceutical Industries Ltd rose by 0.31% to close the day at $32.19.