- Allurion Technologies (ALUR, Financial) submits final module of PMA application to FDA.
- Additional analyses from AUDACITY Study meet pre-specified co-primary endpoints.
- Significant weight loss observed in treatment group using Allurion Balloon.
Allurion Technologies, Inc. (ALUR), a leader in metabolically healthy weight loss innovations, has successfully submitted the fourth and final module of its Pre-Market Approval (PMA) application to the Food & Drug Administration (FDA). This submission includes additional supportive analyses from the pivotal AUDACITY Study, which demonstrated success in meeting both pre-specified co-primary endpoints.
The AUDACITY Study highlighted a difference in weight loss outcomes between treatment and control groups. At 48 weeks, the mean difference in total body weight loss was 4.34%, and the super-superiority margin reached 3.14%, exceeding the pre-specified margin of 3% (p= .0142). The extended results at 40 weeks showed a mean difference of 4.90%, with a super-superiority margin of 3.75% (p= .0006).
Dr. Shantanu Gaur, Founder and CEO of Allurion, expressed optimism about the PMA submission and the additional analyses that bolster the efficacy of the Allurion Balloon. These results are vital as the study is the first FDA pivotal trial on an intragastric balloon for weight loss reporting primary outcomes beyond nine months.
This study involved 550 participants randomized 1:1 to receive either two cycles of the Allurion Balloon or moderate-intensity lifestyle therapy as a control. The treatment group received their first Allurion Balloon at Week 0, which passed at approximately Week 16, followed by a second balloon at Week 24, passing around Week 40. The co-primary endpoints measured the responder rate and the percentage of total body weight loss at Week 48.
As Allurion awaits FDA approval, the company remains committed to advancing its innovative weight loss solutions, leveraging its Virtual Care Suite and the Allurion Balloon, which is currently investigational in the United States.
