Allergan said late Wednesday night that the FDA approved Lap-Band, its adjustable gastric banding system, for broader use.
The device approval shows a contrast to the federal agency's stance on drugs that would treat obesity.
Allergan launched a campaign in May to encourage policymakers to recognize obesity as a disease. The Irvine, CA-based drug and device maker is working with Chandler Chicco Agency on the "Choosing Health over Obesity Inspiring Change through Empowerment" effort.
Lap-Band is now approved for adult patients with a body mass index between 30 and 40 and who have been diagnosed with at least one obesity-related condition such as Type 2 diabetes or high blood pressure. It had previously only been available to severely obese adult patients with a body mass index of 40 or more, or patients with a BMI of 35 and diagnosis of at least one obesity-related condition.
More than 26 million adults in the US are now eligible for Lap-Band surgery, compared to the 15 million to 18 million that were previously eligible, according to Allergan's estimates.