Speakers highlight 2024 regulatory moves in hypertension, lipid, diabetes therapies
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Key takeaways:
- Speakers highlighted recent regulatory moves in the areas of hypertension, lipids and diabetes.
- Presentations included approvals in BP management, breakthrough lipid therapies and rejected diabetes therapeutics.
There have been many recent regulatory updates in the areas of blood pressure management, dyslipidemia and diabetes management, speakers reported.
Speakers at the Cardiometabolic Health Congress presented an outline of recently announced FDA approvals, breakthrough designations and regulatory rejections.
FDA updates in hypertension treatment
To highlight recent FDA updates in treatment for hypertension, Keith C. Ferdinand, MD the Gerald S. Berenson Endowed Chair in Preventive Cardiology, professor of medicine in the John W. Deming Department of Medicine at Tulane University School of Medicine and a member of the Healio | Cardiology Today Editorial Board, presented the year in review.
FDA approves expanded indication of furosemide injection for NYHA class IV heart failure
scPharmaceuticals Inc. announced the FDA approved the supplemental new drug application to expand the indication of its self-administered subcutaneous furosemide injection for patients with heart failure. Read more
FDA approves aprocitentan for treatment of hypertension in adults with uncontrolled BP
Idorsia announced that the FDA has approved aprocitentan, its antihypertensive drug, for treatment of hypertension in combination with other drugs in patients whose BP is not adequately controlled on other drugs. Read more
Health care providers ‘excited’ about convenient, safe OTC birth control pill
In March, the first nonprescription, over-the-counter contraceptive pill became available to buy in stores and online. The progestin-only pill is an important step in boosting access to birth control, according to women’s health providers. Read more
FDA approves first renal denervation device to treat hypertension
The FDA approved the first renal denervation device to treat adults with hypertension not adequately controlled with lifestyle changes and medications, ReCor Medical announced. Read more
FDA approves second renal denervation device to treat hypertension
The FDA approved a second renal denervation device to treat adults with uncontrolled hypertension despite an advisory panel’s vote regarding that system’s risks and benefits, Medtronic announced. Read more
“In a scientific statement that came out from the American Heart Association, earlier this year, Jennifer Cluett, MD, FAHA, was the lead chair, and in it we suggest that you have to make sure that you validate your blood pressure; you measure mental blood pressure right; prescribe appropriate medications; exclude secondary causes; and then use what's called shared decision-making,” Ferdinand said during the presentation. “You must work with patients to control their blood pressure together, making the decision together.”
FDA update in lipids
Christie M. Ballantyne, MD, FACC, FACP, FAHA, FNLA, chief of the section of cardiovascular research, professor of medicine at Baylor College of Medicine and co-chair of the Cardiometabolic Health Congress (CMHC), provided the year in review for lipid-related FDA news.
Ballantyne stated during the presentation that, while there may not have been many FDA approvals in this space in 2024 so far, there is much currently in the pipeline.
One drug he discussed was the receipt of breakthrough status for plozasiran (Arrowhead).
Plozasiran secures FDA breakthrough status for FCS, closing gap with rival olezarsen
The FDA has granted breakthrough therapy designation to Arrowhead Pharmaceuticals’ plozasiran, coupled with diet, to decrease triglycerides in patients with familial chylomicronemia syndrome, according to a company release. Read more
FDA updates in diabetes
Robert H. Eckel, MD, emeritus professor of medicine in the divisions of cardiology and endocrinology, diabetes and metabolism, emeritus professor of physiology and biophysics and Charles A. Boettcher II Chair in Atherosclerosis at the University of Colorado Anschutz Medical Campus, provided CMHC attendees with important updates in not only FDA approvals of diabetes therapies, but also rejections.
Eckel presented on behalf of Anne L. Peters, MD, a Healio | Endocrine Today Editorial Board member, professor of clinical medicine at the University of Southern California Keck School of Medicine and director of the University of Southern California Westside Center for Diabetes, who was unable to attend the congress.
FDA clears implantable CGM with sensor that lasts up to 1 year
The FDA has cleared a continuous glucose monitoring system with an implantable sensor that can be worn for up to 1 year for adults aged 18 years and older with type 1 or type 2 diabetes, according to a press release. Read more
“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,” Eckel said. “With traditional CGMs, it's more like every 10 to 14 days ... The sensor survival ratings are over 90% with the Eversense 365, and maybe two-thirds to 80% with these other CGM systems.”
FDA rejects once-weekly basal insulin for diabetes, requests more information
The FDA declined to approve once-weekly basal insulin icodec for the treatment of diabetes and is requesting more information from Novo Nordisk, according to a company press release. Read more
FDA committee rejects recommending once-weekly insulin for approval in type 1 diabetes
An FDA committee declined to recommend approval for a once-weekly insulin to improve glycemic control for adults with type 1 diabetes. Read more
FDA approves next-generation CGM with two-step insertion process
FDA approved Medtronic’s next-generation continuous glucose monitor for people with diabetes, according to an industry press release. Read more
“[Simplera Sync] is something to keep your eye out eye in terms of another potential application for people wanting infusions and automatic insulin delivery systems,” Eckel said.
FDA clears tubeless automated insulin delivery system for adults with type 2 diabetes
The FDA has cleared an automated insulin delivery system for adults aged 18 years and older with type 2 diabetes, Insulet Corp. announced. Read more
Tubeless insulin patch pump receives FDA clearance for type 1 and type 2 diabetes
The FDA has granted 510(k) clearance for an insulin patch pump for adults with type 1 or type 2 diabetes, Embecta Corp. announced. Read more
References:
- Ballantyne CM, et al. FDA Update and Late Breaking Trials.
- Peters AL, et al. FDA Update and Late Breaking Trials. Both presented at: Cardiometabolic Health Congress; Oct. 17-19, 2024; Boston.
- Cluett JL, et al. Hypertension. 2024;doi:10.1161/HYP.0000000000000240.
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Ferdinand KC, et al. FDA Update and Late Breaking Trials. Presented at: Cardiometabolic Health Congress; Oct. 17-19, 2024; Boston.
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