FDA News, Week of Aug 10, 2015 – Drug and Device Digest

FDA Voice

precision medicine

Advancing precision medicine by enabling a collaborative informatics community

  •  FDA proposing an informatics community ‘precisionFDA .’ in support of President Obama’s Precision Medicine Initiative
  • Use of next generation sequencing (NGS) to determine future risk of disease, behavior, or treatment choices
  • Novel regulatory framework – using shared databases to ease regulatory burden

Storyline : Innovative and collaborative proposals along with novel regulatory pathways being proposed by the FDA to develop individualized treatment options



Frances Oldham Kelsey, Ph.D., M.D.: A Pioneer in Public Health and Protection of Patients

kelseyJoined FDA in 1960 as a medical officer

Refused to approve thalidomide because of inadequate evidence about its safety

Spared the tragic birth defects and deaths experienced by patients in those countries where thalidomide was available

Kefauver-Harris Drug Amendments became law in 1962 – mandating “substantial evidence” of a drug’s effectiveness + Safety

Revered as a leader in drug safety and the protection of patients


FDA approved

ORBERA™ Intragastric Balloon System (Apollo Endosurgery, Inc. Austin, TX)


Reg pathway: PMA

Ex-US approvals : Several, since the 1990s. PMA supported by safety data from clinical product surveillance and studies in Australia and France

Indications for Use: Adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of ≥ 30 and ≤ 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss.

Description:  Non-surgical aid, soft, smooth silicone elastomer balloon that is placed in the stomach endoscopically and filled with saline, causing it to expand into a spherical shape. The filled balloon is designed to occupy space and move freely within the stomach (Figure). Self-sealing valve permits detachment of the balloon from external catheters used during the ORBERA™ placement procedure


  • Single pivotal study (IB-005), n= 448
  • Two co-primary endpoints : Percent excess weight loss (%EWL) at Month 9, and Percent subjects with ‘significantly greater weight loss’ (≥ 15% EWL).

  • Did not meet prespecified EWL target; however treatment group showed significant Total Body Weight Loss (TBWL, 5.7% over control) at month 9.
  • Met second co-primary endpoint with 45.6% treated subjects achieving at least 15% EWL over control
  •  Treated group lost significantly more weight than the control group over the study and was able to maintained significant weight loss through Month 12; 6 months after removal of the device.


  • No unanticipated adverse device effects or deaths; 5% Serious Adverse events due to device intolerance


  • Probable benefits of demonstrated statistically significant weight loss over the control group at device removal (6 months); maintenance of 70% of the weight loss out to 12 months
  • Risks for patients developing adverse events related to the device
  • Limited less invasive obesity treatment options currently available.  ORBERA  can offer patients significant weight loss, with low risk,  when used in conjunction with a diet and exercise program.


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