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In the future, the month of March 2023 will be remembered as a turning point for the diabetes community.
In the 31-day span, the community saw the biggest reduction in insulin pricing in decades, regulatory news related to diabetes therapies and technology, and celebrated the 10-year anniversary of the approval of a truly game-changing class of medications in SGLT2 inhibitors. In our month in review, we highlight these topics and shine light on recent news in the world of hepatology.
March 2023 was no doubt a historic month for the diabetes community. Beginning on March 1 with Eli Lilly and Company’s announcement, the community witnessed 3 major insulin suppliers announce significant list price reductions on their insulin products. As part of our endocrine month in review, we are highlighting the reaction to this news from the diabetes community and a special edition episode of Diabetes Dialogue.
It was not long after Eli Lilly and Company’s announcement before major organizations and advocacy groups, including the Endocrine Society and the American Diabetes Association, began to release celebratory statements. To commemorate the news and predict the impact of this type of news on the quality of life for people with diabetes.
Editor’s note: This story was published prior to updates from Sanofi and Novo Nordisk.
The final episode of Diabetes Dialogue in the month of March, this special edition episode tackles 3 major topics: the 10-year anniversary of SGLT2 inhibitors, getting to the brass tacks on the reductions in insulin price news, and insight into the results of the MOMENTUM trial, which examined use of pemvidutide as a treatment for obesity.
Check out the preview below:
Our coverage during the month of March included a focus on nonalcoholic fatty liver (NAFLD). With a growing prevalence and no approved treatments, NAFLD represents a large unmet need within patient populations with and without diabetes. In our month in review, we have chosen to highlight a pair of popular stories related to NAFLD.
The impact of GLP-1 receptor agonist use in NAFLD or NASH has been the subject of debate in the diabetes community, with some evidence pointing to a positive benefit as it relates to liver fat content. Now, a phase 2 trial is offering further insight into the effects of semaglutide 2.4 mg.
Results of the trial indicated use did not significantly improve fibrosis or achievement of NASH resolution versus placebo in patients with NASH-related compensated cirrhosis. However, investigators noted use was associated with improvements in cardiometabolic risk parameters and did not lead to new safety concerns in patients with cirrhosis.
As part of our “The Untreated” feature series, our editorial team sought to encapsulate the unmet need currently existing within the community. In the article, key opinion leaders in hepatology offer insight into the struggles faced by patients and the prospect of a potential therapy in obeticholic acid, which has a PDUFA date of June 22, 2023.
It is rare a month goes by without news from the US Food and Drug Administration (FDA) related to diabetes. March was no exception. In this portion, we highlight 3 pieces of content related to FDA news in the diabetes space from the month of March, including a new approval for an flash glucose monitor, a supplemental new drug application (sNDA) for empagliflozin in pediatric populations, and a feature celebrating the 10-year anniversary of the approval of canagliflozin in 2013.
On March 6, Abbott announced the FDA had granted clearance to the company’s FreeStyle Libre 2 and FreeStyle Libre 3 integrated continuous glucose monitoring (iCGM) sensors for integration with automated insulin delivery systems (AIDs). The clearance, which allows use of modified FreeStyle Libre 2 and FreeStyle Libre 3 sensors, also indicates the modified sensors for use in children as young as 2 years old and for wear time up to 15 days.
On March 8, Boehringer Ingelheim and Eli Lilly and Company announced the submission of an sNDA for empagliflozin as an adjunct to diet and exercise for improving glycemic control in people ages 10 years and older with type 2 diabetes. The application is based on the results of the phase 3 DINAMO trial and, if approved, empagliflozin would become the SGLT2 inhibitor to receive such an indication from the FDA.
Few classes have had the same measurable impact on cardiometabolic health as SGLT2 inhibitors have in just a decade. To celebrate the 10-year anniversary of the FDA’s approval of canagliflozin in 2013, this feature pulls together perspective from key opinion leaders and care providers in diabetes, heart failure, and nephrology to offer perspective on the ascent of SGLT2 inhibitors from glucose-lowering agent to a centerpiece in treatment algorithms across a multitude of disease states.
Check out this preview from the accompanying podcast episode included in the feature: