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Top FDA Approvals in Diabetes Care from the First Half of 2022

Few, if any, diseases in medicine have seen advances in therapeutics and technology at the same rate as diabetes mellitus in the last decade. With so many advances, regulatory bodies, including the US Food and Drug Administration (FDA), have been claiming headlines for practice-changing approvals on a yearly basis and 2022 has been no different.

In a field where historic advances have become the norm, the first 6 months of 2022 have been a whirlwind for the diabetes community, with approvals for a first-in-class agent, an increased dose of a popular GLP-1 RA, and multiple continuous glucose monitoring (CGM) systems.

To highlight the breakthroughs seen within diabetes care from the first half of 2022, EndocrinologyNetwork’s editorial staff has compiled a list of the most popular content related to FDA approvals and decisions from 2022 so far.

*Editor’s Note: Approvals are listed in chronological order from least to most recent.

Top FDA Approvals in Diabetes from the First Half of 2022

FDA Approves Omnipod 5 AID System for Type 1 Diabetes in Ages 6 and Older

Insulet Corporation announced the FDA’s approval of the Omnipod 5 Automated Insulin Delivery System for use in individuals aged 6 years and older with type 1 diabetes in a press release on Jan. 28. According to the release from Insulet Corporation, the approval for Omnipod 5 makes it the first tubeless automated insulin delivery system with the ability to integrate with the Dexcom G6 continuous glucose Monitoring System and a compatible smartphone to automatically adjust insulin and protect against glycemic events.

Related Coverage: In a 2021 panel discussion moderated by Dhiren Patel, PharmD, panelists Robert Busch, MD, and Diana Isaacs, PharmD, discuss new CGM technology, including a preview of the Omnipod 5, which had not yet received approval at the time.

US FDA Approves Eversense E3 CGM System, Allows Use for Up to 6 Months

Senseonics announced the FDA’s approval of the Eversense E3 Continuous Glucose Monitoring System and plans for a commercial launch through Ascension Diabetes Care in a press release on Feb. 11. With approval based on results of the PROMISE study, the approval for the CGM system provides up to 6 months of longevity due to a proprietary sacrificial boronic acid (SBA) technology, according to the release from Senseonics.

Related Coverage: Full results of the PROMISE study were published in the journal of Diabetes Technology & Therapeutics.

Tandem Diabetes Receives FDA Clearance for t:connect mobile app

Tandem Diabetes Care Incorporated announced the FDA granted clearance for bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app in a press release on Feb. 18. With a series of limited group launches occurring in the spring and an expanded launch expected in the summer of 2022, the free t:connect mobile app, which is designed to offer t:slim X2 insulin pump users the ability to program and cancel bolus insulin requests through a smartphone, is the first-ever FDA-cleared smartphone application capable of initiating insulin delivery on both iOS and Android operating systems.

FDA Approves 2.0 mg Dose of Semaglutide

Novo Nordisk announced the FDA’s approval of a 2.0 mg dose of semaglutide (Ozempic) for use in patients with type 2 diabetes in a press release on March 29. Based on results of the SUSTAIN FORTE trial, the specific indication for the once-weekly GLP-1 RA is as an adjunct therapy to accompany diet and exercise for improving blood sugar in adults with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and a history of cardiovascular disease.

Related Coverage: At ADA 2021, Endocrinology Network covered a pair of studies detailing the reductions in HbA1c and body weight achieved with semaglutide 2.0 mg compared with the 1.0 mg formulation observed within the SUSTAIN FORTE trial.

Tirzepatide (Mounjaro) Wins FDA Approval for Type 2 Diabetes

Eli Lilly and Company announced the FDA’s approval of tirzepatide (Mounjaro) for improving blood sugar in adult patients with type 2 diabetes in a press release on May 13. Based on results of the SURPASS program, the specific indication for tirzepatide is as an adjunct o diet and exercise for improving glycemic control in adults with type 2 diabetes and the agent will be made available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg doses.

Related Coverage: On June 7, Eli Lilly and Company announced tirzepatide is available in US pharmacies.

FreeStyle Libre 3 Receives FDA Clearance for Diabetes in Patients 4 Years and Older

Abbott announced the FDA’s approval of the FreeStyle Libre 3 CGM system for by people aged 4 years and older in a press release on May 31. Billed as the world’s smallest, thinnest, and most accurate 14-day glucose sensor, the FreeStyle Libre 3 system is the size of 2 stacked US pennies and has a Bluetooth integration range of up to 33 feet. According to Abbott, the FreeStyle Libre 3 system is the first continuous glucose monitoring system to demonstrate a sub 8% MARD, with a 7.9% overall MARD.

For more on the latest regulatory decisions, check out our FDA News resource center.