FDA Roundup: New Options for Obesity, Blood Clots, Influenza
Maestro Rechargeable System: Obesity
The FDA has approved the Maestro Rechargeable System (EnteroMedics) the treatment of obesity in certain adults.1
This “hunger pacemaker” works by targeting the nerves between the brain and stomach that control the sensations of hunger and fullness with intermittent electrical pulses. It is intended for use in adults who have been unsuccessful at losing weight through weight loss programs, have a BMI of 35 to 45, and at least 1 obesity-related comorbidity.
Its safety and effectiveness were tested in a clinical trial of 233 patients. After 12 months, the group using the Maestro lost 8.5% more excess weight than the control group. Of these, 52.5% lost 20% of their excess weight.
Adverse effects of the system include nausea, pain, vomiting, heartburn, and problems swallowing.
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Savaysa: Blood Clots
The FDA has approved Savaysa (edoxaban tablets, Daiichi Sankyo Co, Ltd) for the reduction of risk of stroke and dangerous blood cloths in patients with atrial fibrillation not caused by a heart valve issue.2
The drug is also approved for the treatment of deep-vein thrombosis in patients who have already been treated with injected or infused anti-clotting drugs for 5 to 10 days.
The drug’s safety and efficacy was evaluated in 2 clinical trials. One study of 21,105 participants found that treatment in patients with atrial fibrillation with Savaysa resulted in significantly less bleeding risk than treatment with warfarin.
In the second trial of 8,292 participants with deep-vein thrombosis, 3.2% taking Savaysa had recurrent venous thromboembolism versus 3.5% of those taking warfarin.
The most common side effects reported were bleeding and anemia.
Alere i Influenza A & B test: Influenza
The FDA has granted a waiver allowing the Alere i Influenza A & B test to be distributed to a variety of healthcare settings, rather than being reserved for use only within certain laboratories.3
The test, which uses a nasal swab to identify influenza infection in as little as 15 minutes, may now be used in physicians’ offices, emergency rooms, and clinics.
“Today’s decision allows the first nucleic acid-based test to be available in clinical settings that previously could not use this technology,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
“Once cleared by FDA, such tests can allow health care professionals to receive test results more quickly to inform further diagnostic and treatment decisions.”
The waiver was granted after the tests manufacturer submitted data regarding ease of use and low risk of false positive results, even when used by untrained operators. In a review of data from more than 500 patients with symptoms of respiratory viral infection, the test demonstrated a high accuracy when compared to an FDA-approved test for influenza.
—Michael Potts
References:
- FDA. FDA approves first-of-kind device to treat obesity [press release]. January 14, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430223.htm. Accessed January 16, 2015.
- FDA. FDA approves anti-clotting drug Savaysa [press release]. January 8, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm. Accessed January 16, 2015.
- FDA. FDA grants first CLIA waiver for nucleic acid-based flu diagnostic test [press release]. January 6, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429127.htm. Accessed January 16, 2015.