Regulatory Updates in Cardiometabolic Health: Hypertension, Lipids, and Diabetes Therapies
Key Insights
The FDA approved an expanded indication for subcutaneous furosemide injection for heart failure (search) patients, offering a convenient self-administration option.
Aprocitentan received FDA approval for hypertension (search), providing a new treatment option for adults with uncontrolled blood pressure despite other medications.
The FDA cleared a continuous glucose monitoring (CGM) system featuring an implantable sensor lasting up to one year for diabetes (search) management.
Recent regulatory actions concerning hypertension (search), lipid management, and diabetes (search) therapies were highlighted at the Cardiometabolic Health Congress. Experts discussed key FDA approvals, breakthrough designations, and notable rejections impacting clinical practice.
Hypertension Treatment Updates
Keith C. Ferdinand, MD, reviewed recent FDA actions in hypertension (search) treatment, emphasizing the importance of validated blood pressure measurements and shared decision-making with patients. Key approvals include:
- Furosemide Injection: scPharmaceuticals Inc. received FDA approval for an expanded indication of its self-administered subcutaneous furosemide injection, aimed at patients with NYHA class IV heart failure.
- Aprocitentan: Idorsia's aprocitentan was approved for treating hypertension in adults whose blood pressure remains uncontrolled despite other medications. This approval offers a new therapeutic option for resistant hypertension.
- Renal Denervation Devices: The FDA approved two renal denervation devices for hypertension, offering a device-based approach for patients not adequately controlled with lifestyle changes and medications.
Ferdinand emphasized the importance of patient involvement in managing hypertension (search), stating, "You must work with patients to control their blood pressure together, making the decision together."
Lipid Management Updates
Christie M. Ballantyne, MD, provided an overview of recent FDA news related to lipid management, noting that while approvals may be limited in 2024, the pipeline remains robust. A significant highlight was the breakthrough therapy designation granted to plozasiran.
- Plozasiran: Arrowhead Pharmaceuticals' plozasiran received breakthrough therapy designation for reducing triglycerides in patients with familial chylomicronemia syndrome (FCS), potentially addressing a critical unmet need.
Diabetes Management Updates
Robert H. Eckel, MD, presented updates on FDA actions in diabetes (search) therapies, covering both approvals and rejections. Notable developments include:
- Implantable CGM: The FDA cleared a continuous glucose monitoring system featuring an implantable sensor that can be worn for up to one year in adults with type 1 or type 2 diabetes. Eckel noted the improved feasibility, stating, "Here's a step in the right direction in terms of feasibility, now with now approval by the FDA for the use of a once per year insertion."
- Next-Generation CGM: Medtronic received FDA approval for its next-generation continuous glucose monitor for people with diabetes.
- Tubeless Insulin Delivery: The FDA cleared a tubeless automated insulin delivery system for adults with type 2 diabetes (Insulet Corp.) and an insulin patch pump for adults with type 1 and type 2 diabetes (Embecta Corp.).
- Insulin Icodec Rejection: The FDA declined to approve once-weekly basal insulin icodec for diabetes, requesting additional information from Novo Nordisk. An FDA committee also declined to recommend approval for once-weekly insulin in type 1 diabetes.