Top FDA News in Diabetes for 2022

With less than a week to go until the close of 2022, our editorial team is kicking off the final week of the year by recapping some of our most popular stories and content from the past year.

Here, we are highlighting the most popular regulatory news from the past year. For our readers, we’ve broken down this list into top diabetes drug approvals and top diabetes technology clearances. Below, you will find a brief recap of each and links to any associated coverage.

Top Drug Approvals in Diabetes for 2022

Tirzepatide

Tirzepatide (Mounjaro) Wins FDA Approval for Type 2 Diabetes

The US Food and Drug Administration has granted approval to tirzepatide (Mounjaro) as an adjunct therapy to diet and exercise for improving glycemic control in adults with type 2 diabetes, according to a release from the FDA.

Announced on May 13, approval of the first-in-class, once-weekly dual GLP-1/GIP agonist, which is expected to be available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg doses, is based on data from the SURPASS program.

Semaglutide

FDA Approves 2.0 mg Dose of Semaglutide

The US Food and Drug Administration has approved a 2 mg dose of semaglutide (Ozempic) for use in patients with type 2 diabetes, according to a statement from Novo Nordisk.

Announced on March 28, the approval for the 2 mg dose of Novo Nordisk’s once-weekly GLP-1 RA is approved 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.

Teplizumab

Teplizumab Receives FDA Approval for Delaying Type 1 Diabetes

The fight against diabetes has taken a historic turn, with the US Food and Drug Administration approval of teplizumab (Tzield) injection to delay the onset of type 1 diabetes in adults and pediatric patients.

Announced in a statement on November 17, the FDA’s approval indicates the anti-CD3 antibody from Provention Bio, which will be marketed through a partnership with Sanofi, for delaying the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Related: Diabetes Dialogue: What Teplizumab Means for Type 1 Diabetes (See Preview Below)

Top Clearances in Diabetes Technology for 2022

Omnipod 5

Omnipod 5 Receives Clearance for Use in Ages 2 and Older with Type 1 Diabetes

The US Food and Drug Administration has approved the Omnipod 5 Automated Insulin Delivery System for use in individuals aged 6 years and older with type 1 diabetes, according to a statement from Insulet Corporation.

Announced on January 28, Insulet suggests the approval Omnipod 5 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.

Freestyle Libre 3

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

The FreeStyle Libre 3 system from Abbott has received clearance from the US Food and Drug Administration for use by people aged 4 years and older living with diabetes.

Announced by Abbott in a statement on May 31, the FreeStyle Libre 3 is expected to be available later this year at participating pharmacies and will be available at the same price as previous versions of the system.

EverSense E3

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

The US Food and Drug Administration has approved the Eversense E3 Continuous Glucose Monitoring System, which uses proprietary sacrificial boronic acid (SBA) technology to extend longevity to 6 months, according to a press release from Senseonics.

The company noted plans for the Eversense E3 to be available to patients in the US through Ascensia Diabetes Care beginning in the second quarter of 2022.

Dexcom G7

Dexcom G7 CGM System Receives FDA Clearance

Dexcom has announced their Dexcom G7 Continuous Glucose Monitoring (CGM) system has received clearance from the US Food and Drug Administration for people with all types of diabetes aged 2 years and older.

Announced on December 8, the Dexcom G7 boasts an overall MARD of 8.2% and is billed by the company as the most covered CGM on the market.

Diabetes Dialogue: December 2022 (See Preview Below)