CMHC Pulse Blog

The FDA continues to advance treatment options for cardiometabolic and cardiorenal conditions. Explore a quick recap of key approvals and pending/late-breaking decisions, reflecting significant progress in addressing these complex, interrelated diseases: 

July 2024 Approvals 

Simplera System (P160007/S047) (Approval: July 24, 2024) This Continuous Glucose Monitoring System provides real-time glucose monitoring through its app, replacing fingersticks.

August 2024 Approvals 

Minima Stent System (P240003) (Approval Date: August 28, 2024) The Minima Stent System is an expandable cobalt-chromium metal mesh tube to reopen blood vessels in neonates, infants, and children with Coarctation of the Aorta and Pulmonary Artery Stenosis, specifically designed to expand as younger patients grow.

September 2024 Approvals 

Flurpiridaz F 18 

• Approval Date: September 27, 2024 

• Indication: A radioactive positron emission tomography (PET) tracer for imaging myocardial ischemia and infarction in adults with suspected or known coronary artery disease. 

• Significance: Flurpiridaz F 18 enhances diagnostic precision for coronary artery disease (CAD) and myocardial perfusion imaging, aiding in the early and accurate detection of cardiac conditions. 

• AURORA Phase III Trial: Delivered a sensitivity of 74-89% and specificity of 53-70% in detecting significant CAD compared to standard single-photon emission computed tomography (SPECT) imaging in diagnosing CAD, with reduced radiation exposure and improved image quality. 

November 2024 Approvals 

Acoramidis 

• Approval Date: November 22, 2024 

• Indication: Approved for adults with transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and severe cardiac condition. 

• Significance: Acoramidis is a near-complete transthyretin (TTR) stabilizer (≥90%) that significantly reduces cardiovascular-related hospitalizations and mortality in patients with ATTR-CM. This marks a major milestone as the second FDA-approved therapy for this condition, with intellectual property protection until at least 2039. 

• ATTRibute-CM Phase III Trial: Achieved a 42% reduction in all-cause mortality and cardiovascular-related hospitalizations and a 50% reduction in cumulative cardiovascular hospitalizations at Month 30, with a favorable safety profile. 

Landiolol 

• Approval Date: November 22, 2024 

• Indication: Approved for the treatment of supraventricular tachycardia (SVT). 

• Significance: Landiolol offers a new, highly selective beta-1 blocker for managing abnormally fast heart rhythms, addressing an important need in cardiac health management. 

• Studies on Supraventricular Tachycardia: 

  • 5 studies, a total of 317 adults. 

  • Heart rate reduction within 10 minutes: 

  • Landiolol: 40%-90%. 

  • Placebo: 0%-11%. 

  • Heart rate decrease criteria: >20% decrease, HR <100 bpm, or arrhythmia cessation. 

  • Adverse events: 

  • Landiolol: 9.9%. 

  • Placebo: 1%. 

Late Breaking December 2024 FDA Decisions

Olezarsen (RNA-Targeted Therapy) 

• Approval Date: December 19, 2024 

• Indication: Treatment for familial chylomicronemia syndrome (FCS). 

• Significance: The first FDA-approved therapy for FCS, Olezarsen will revolutionize the management of this rare genetic disorder characterized by dangerously high triglyceride levels and recurrent pancreatitis. 

• BRIDGE-TIMI 73a Phase IIb Trial: Demonstrated significant reductions in triglyceride levels and improved safety in the BRIDGE–TIMI 73a trial, with potential applications in severe hypertriglyceridemia. 

Tirzepatide

• Approval Date: December 19, 2024

• Indication: Moderate to severe obstructive sleep apnea (OSA) in adults with obesity, combined with a reduced-calorie diet and increased physical activity.

• Significance: The first FDA-approved drug for OSA, Tirzepatide reduces weight and improves OSA symptoms by activating intestinal hormone receptors (GLP-1, GIP).

• SURMOUNT-OSA Phase III Trial: Two randomized, double-blind studies showed significant reductions in apnea-hypopnea index (AHI) and weight after 52 weeks, with improved OSA remission rates.

Emerging Trends in Cardiometabolic and Cardiorenal Therapeutics 

These approvals and pending decisions underscore the FDA’s ongoing efforts to advance innovative therapies for rare diseases, metabolic disorders, and complex cardiovascular conditions. By prioritizing patient-centric innovation, these advancements emphasize the importance of addressing unmet medical needs. 

For healthcare professionals, staying informed about these developments is vital to improving outcomes and navigating an evolving treatment landscape. To explore FDA approvals from January to July 2024, click here. Keep following the Cardiometabolic Health Congress (CMHC) for continuous education and engagement with the latest clinical research to advance clinical practices and patient care.