FDA News

May 2023 was another significant month for the cardiometabolic community, with a handful of approvals from the US Food and Drug Administration (FDA) paving the way with new technologies and new therapies for patients with diabetes and related comorbidities.

FDA Grants Clearance to iLet Bionic Pancreas

Announced on May 19, the FDA granted clearance to the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people aged 6 years or older with type 1 diabetes (T1D). When combined with a compatible FDA-cleared integrated continuous glucose monitor, the technology will form the iLet Bionic Pancreas and could usher in a new era of glycemic control.

The approval arrived through the 510(k) premarket clearance pathway. The adaptive closed-loop algorithm requires only a user’s body weight for startup and removes the need to manually adjust insulin pump settings, adapting to a user’s individual insulin needs over time.

Diabetes Dialogue: What to Know about the iLet Bionic Pancreas

The latest episode of Diabetes Dialogue published in May tackled the FDA clearance of the iLet Bionic Pancreas and provided perspective on what to know about the technology. Hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist and coordinator of the Remote Monitoring Program at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center sat down to investigate the implications of the clearance, misconceptions around the device, and ponder the future of the technology for patients with diabetes.

FDA Approves Sotagliflozin for Treatment of Heart Failure

On May 26, the FDA approved sotagliflozin (Inpefa) for the treatment of heart failure across the full range of left ventricular ejection fraction. Granted to Lexicon Pharmaceuticals, the approval is the first for an SGLT 1/2 inhibitor, based on positive data from the SOLOIST-WHF and SCORED trials. It joins dapagliflozin and empagliflozin as the third therapy boasting SGLT2 inhibition as a mechanism of action in heart failure across the spectrum of ejection fraction.

Sotagliflozin is indicated for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes (T2D), chronic kidney disease, and other cardiovascular risk factors. The therapy was once pushed as a T1D medication and received a complete response letter (CRL) from the FDA in July 2019. Now, given its approval, Lexicon expects it to become commercially available in the US by the end of June 2023.

Exploring the Impact of the Sotagliflozin Approval, with Deepak Bhatt, MD, MPH

For more perspective on the impact of the sotagliflozin approval, the HCPLive editorial team sat down with Deepak Bhatt, MD, MPH. Bhatt described the potential future research opportunities for the SGLT1/2 inhibitor and elaborated on the impact of a 3rd agent boasting SGLT2 inhibition receiving approval for heart failure.

FDA Issues Complete Response Letter for TransCon PTH in Hypoparathyroidism

However, not all FDA news in diabetes was as successful, as the FDA issued a complete response letter (CRL) to Ascendis Pharma for palopegteriparatide (TransCon PTH) as a treatment for hypoparathyroidism. Announced on May 1, the CRL cited concerns related to the manufacturing control strategy for variability of delivered dose in the drug/device combination product.

However, the CRL did not share concerns regarding clinical data submitted as part of the New Drug Application (NDA) package and did not request additional phase 3 studies or data. The company indicated they will request a Type A meeting with the FDA to determine the path forward for the product. The release noted that people with hypoparathyroidism, a rare disorder, need new treatment options and they plan to work urgently to resolve the FDA’s concerns.

Phase 2 Data

Phase 2b Trial Suggests Efficacy of Oral Danuglipron for Glycemic Control in T2D

New phase 2b clinical trial data indicated danuglipron, a novel, oral, small molecule glucagon-like peptide-1 receptor (GLP-1R) agonist had an efficacy and safety profile consistent with currently available peptide agonists in adults with T2D. The administration of twice daily danuglipron for 16 weeks reduced HbA1c and fasting plasma glucose at all dose levels studied, as well as body weight at doses of ≥80mg, compared with placebo.

Danuglipron is being investigated as an adjunct to diet and exercise to improve glycemic control in those with T2D. Semaglutide is the only GLP-1R agonist available for oral administration but requires strict fasting requirements before and after administration. The effects on weight loss with danuglipron were of similar magnitude to those observed in phase 2 data for oral semaglutide, according to the analysis.

BI 456906 Shows Promise, Reducing Body Weight Up to 14.9%, in Phase 2 Trial

Topline results of the phase 2 dose-finding trial for BI 456906 suggest the use of dual glucagon/GLP-1 receptor agonist could help patients lose up to 14.9% of their body weight in people with obesity or overweight without T2D over 46 weeks. Excitement surrounding developments in obesity management has been paramount since the presentation of SURMOUNT-1 results on tirzepatide at the American Diabetes Association (ADA) 2022 Scientific Sessions.

Boehringer Ingelheim and Zealand Pharma plan to present the results of the phase 2 dose-finding trial for BI 456906 at the upcoming ADA 2023 Scientific Sessions in June. In addition to the main study results, the companies plan to present an additional analysis of the actual maintenance dose indicating even greater weight loss.

Diabetes Care Across the US

Study Finds Only 1 in 4 with Diabetes in the US are Achieving Treatment Goals

Results from an analysis of data from the National Health and Nutrition Examination Survey (NHANES), suggest approximately 75% of people with diabetes in the United States were not at the American Diabetes Association (ADA)-recommended HbA1c target of ≤7%. The target was achieved by 25.2% of people with T1D, 25.2% among those with T2D using mealtime insulin, and 12.3% among those with T2D using basal-only insulin. The update to the existing literature surrounding trends in HbA1c in basal and mealtime insulin users highlights the need for improved therapeutic tools to better manage glycemic targets in people with diabetes.

California Insulin Biosimilar Plan Could Save $100 Million in Annual Spending

A new cross-sectional analysis of Medicare and commercial insurer spending suggests California’s strategy to produce and market biosimilar insulin at transparent, production-equivalent prices unaffected by rebates could result in an approximate $100 million decrease in health care spending through the state. The data showed the policy initiative could have significant and substantial cost-saving effects for people with diabetes or otherwise needs for insulin access, even after considering insulin cost rebates.