FDA approves Orbera Intragastric Balloon for obesity- Apollo Endosurgery

The FDA has approved the Orbera Intragastric Balloon, from Apollo Endosurgery, to assist adult patients suffering from obesity – with a body mass index (BMI) of 30 to 40 kg/m² – in losing and maintaining weight. Data on Orbera collected in the U.S. clinical trial has shown that the average person lost 3.1 times the weight as compared with diet and exercise alone within six months.

In the U.S. pivotal clinical trial (a multicenter, prospective, randomized, non-blinded comparative study), patients suffering from obesity with a BMI between 30 and 40 kg/m² were randomised to treatment or control in a 1:1 ratio. Detailed findings from the trial show that at month 6, the Orbera group achieved a mean of 38.4% excess weight loss (EWL). Mean total body weight loss (TBWL) at 6 months was 10.2% for the treatment group compared to 3.3% TBWL for the control group. In addition, the Orbera group lost 3.1 times as much weight as the control group at 6 months, lost significantly more weight than the control group over the course of the study, and was able to maintain significant weight loss through month 12 (6 months after removal of the device).

Comment: Apollo Endosurgery acquired rights to the Orbera intragastric balloon with the rest of Allergan’s obesity business. ReShape Medical has completed a successful study of their intragastric balloon for obesity treatment and has now received FDA approval. Allurion Technologies and GI Dynamics are also developing similar systems.