Apollo Endosurgery has received an FDA nod to conclude the LAP-BAND Lower Body Mass Index-approval (LBMI) Study. The move would save the Austin, TX-based company a little more than $5 million.
The trial's termination was based on the availability of long-term safety and effectiveness data of Apollo's LAP-BAND in existing published evidence.
The company gained access to the LAP-BAND technology when it acquired Allergan’s obesity division for about $110 million in 2013. In addition, Apollo also picked up the Orbera Balloon, which was in a bit of controversy in September of last year.
In 2011, FDA granted approval for an expanded indication of the LAP-BAND System to include patients with a BMI in the range of 30 to 35 and with one or more comorbid conditions.
As part of the indication expansion, FDA required Allergan to conduct the LBMI trial, a prospective, multicenter, open-label, post-approval study intended to evaluate the safety and effectiveness of the LAP-BAND System in patients with BMI in the range of 30 to 39.9, with one or more obesity-related comorbidities.
The LBMI Study design called for up to 325 patients from up to 20 clinical study sites to be enrolled. By the end of 2017, the study had enrolled 181 subjects from a total of 13 clinical study sites.
Stellar results from previous studies helped fill in the gaps. Apollo’s final trial report to FDA contained an analysis of clinical data referencing 25 published studies, including HERO-002, which Apollo concluded in September of 2017.
The HERO-002 study showed sustained long-term weight loss over the five-year-period, with the average percent total body weight loss at five-years of 18% plus or minus 12.7%, corresponding to 51.7% excess weight loss; and a device explant rate of 8.74%, which was substantially below the study's safety objective of less than 39.4% at five years.