Australian Therapeutic Goods Administration (TGA) has approved 12 months of treatment for its EndoBarrier Gastrointestinal Liner (the EndoBarrier) to treat patients with Type 2 diabetes and obesity.
Following this approval, EndoBarrier can be commercially launched in Australia.
The EndoBarrier is implanted non-surgically through mouth without cutting any tissue to create a barrier between wall of the intestine and food.
The TGA approval is based on the 500-patient clinical study that demonstrated EndoBarrier improves glycemic control and weight loss over the treatment period.
According to the Australian Diabetes Council (ADC), over 3 million Australian adults above the age of 25 have either diabetes or pre-diabetes.
The EndoBarrier is approved and commercially available in Chile, Europe, Germany, Netherlands and the United Kingdom.