FDA Roundup: OTC Continuous Glucose Monitors, Dapagliflozin for Pediatric T2D


Check out important updates from the FDA for the week of June 10.

FDA Approves 2 New OTC Continuous Glucose Monitors

FDA Roundup: OTC Continuous Glucose Monitors, Dapagliflozin for Pediatric T2D / grandbrothers - stock.adobe.com

FDA Roundup: OTC Continuous Glucose Monitors, Dapagliflozin for Pediatric T2D / grandbrothers - stock.adobe.com

The FDA provided clearance to 2 over-the-counter (OTC) continuous glucose monitor (CGM) systems from Abbott. The new OTC devices are based on the company’s FreeStyle Libre sensing technology, which is the most widely used CGM system in the world. The approvals come shortly after Dexcom received the first CGM OTC approval for its Stelo Glucose Biosensor System.

The Libre Rio is the first OTC CGM that has a measurement range of 40-400 mg/dL, which allows the device to detect extremely low or high glucose events. The CGM provides measurements via a biosensor that is placed on the back of the arm for up to 15 days, which is compatible with a reader or smartphone app.

The Lingo CGM, designed for general adult use, can track glucose levels, provide personalized insights, and give customized coaching to “help people retrain their metabolism and improve their overall well-being.” The system uses a biosensor that is worn on the upper arm for 14 days. Paired with a smartphone app, the device continuously streams glucose data to give users insights on food reactions, exercise and daily stressors.

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FDA Approves Dapagliflozin to Treat Pediatric Patients with Type 2 Diabetes

The FDA approved dapagliflozin (Farxiga) to improve glycemic control in pediatric patients aged 10 years or older with type 2 diabetes (T2D), AstraZeneca announced in a release. The therapy, which is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, was previously approved for adults with T2D as an adjunct to diet and exercise.

The approval was based on data from the T2NOW trial (NCT01042977), in which the therapy demonstrated a significant reduction in A1c levels in pediatric patients with T2D compared to placebo and a safety profile consistent with data seen in adult patient populations. The study results were published in The New England Journal of Medicine.

“The prevalence of type-2 diabetes continues to rise in children and adolescents, yet oral treatment options have remained limited for this population,” Ruud Dobber, executive vice president of the Biopharmaceuticals Business Unit at AstraZeneca, said in a release. “Today’s approval represents an important milestone for pediatric patients living with type-2 diabetes in the US, extending this medicine’s potential benefits to even more patients facing high unmet needs…”

FDA, DOJ Launch Multi-Agency Task Force to Address Illegal E-Cigarettes

The US Department of Justice and the FDA announced the establishment of an interagency federal task force spanning the Bureau of Alcohol, Tobacco, Firearms, and Explosives, the US Marshals Service, the US Postal Inspection Service, and the Federal Trade Commission to curb the illegal distribution and sale of e-cigarettes. In the coming weeks and months, additional agencies may join the cause.

By uniting all available criminal and civil tools in an “all government” approach, the task force hopes to address nicotine addiction among American youth. The team will uphold the Prevent All Cigarette Trafficking Act of 2009, the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, and other authorities, to investigate and prosecute new criminal, civil, seizure, and forfeiture actions associated with e-cigarettes.

In recent years, e-cigarette and nicotine companies have ramped up marketing tactics to appeal to young people. Manufacturers, distributors, and retailers promote candy- and fruit-flavored vapes, bright and colorful designs,2 and packaging meant to be easily concealed from parents and teachers. Although e-cigarette use among young people is down from 5.3 million in 2019 to 2.1 million in 2023, vaping among the population still represents a significant public health issue.

READ MORE: FDA Updates Resource Center

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