CMHC Pulse Blog

The first half of 2024 has ushered in a wave of transformative FDA approvals in cardiorenal metabolic health. Staying informed about these cutting-edge developments is critical for providing exceptional patient care. Join us as we examine the landmark approvals that are revolutionizing patient outcomes.

January 2024 FDA Approvals: Advancing Emergency Cardiac Care 

TZ Medical Adult and Pediatric Multi-Function Defibrillation Electrodes and Adaptors (Approved: 01/09/2024) 

This defibrillator technology marks a crucial advancement in emergency cardiac care, potentially reducing the time a person is in cardiac arrest and increasing the chance for survival.

February 2024 FDA Approvals: Innovations in Cardiovascular Interventions 

1. XACT Carotid Stent System (Approved: 02/07/2024) This approval expands the indications to be used during a Transcarotid Artery Revascularization (TCAR) procedure to prevent future strokes. 

2. Edwards EVOQUE Tricuspid Valve Replacement System (Approved: 02/01/2024) This system provides a novel approach to tricuspid valve replacement, potentially benefiting patients with tricuspid regurgitation without open-heart surgery. 

March 2024 FDA Approvals: A Milestone Month for Cardiorenal metabolic Health 

1. Resmetirom (Rezdiffra) 

• Approved: March 14, 2024 
• Indication: Adults with noncirrhotic nonalcoholic steatohepatitis (NASH), renamed to metabolic dysfunction-associated steatohepatitis (MASH), with moderate to advanced liver fibrosis 
• Administration: Oral 
• Mechanism: Thyroid hormone receptor beta (NR1A2) agonist 
• Developer: Madrigal Pharmaceuticals 
• Significance: The first FDA-approved drug for MASH, a potentially life-threatening condition that afflicts approximately 1.5 million individuals and is growing in the United States. Until this historic approval, no treatment existed. 
• Clinical Trial Results:
  • Reduction in NAFLD activity score 
  • Improved fibrosis 
  • Consistent results across 1,759 patients, regardless of age, gender, type 2 diabetes status, or fibrosis stage 

2. Aprocitentan (Tryvio) 

• Approved: March 20, 2024 

• Indication: Hypertension in adults 

• Administration: Oral 

• Mechanism: Endothelin A and B receptor antagonist 

• Developer: Idorsia Pharmaceuticals 

• Significance: First and only FDA-approved endothelin receptor antagonist for high blood pressure that remains uncontrolled with existing treatments. 

• Clinical Trial Results: 

  • Aprocitentan reduced and maintained lower BP levels over time, both in SiSBP and SiDBP. 

  • BP-lowering effects were consistent across different demographic and clinical subgroups. 

3. Sotatercept (Winrevair) 

• Approved: March 26, 2024 

• Indication: Adults with Pulmonary arterial hypertension (PAH) 

• Administration: Subcutaneous, every three weeks 

• Mechanism: Activin receptor type IIA-Fc (ActRIIA-Fc) fusion protein 

• Developer: Merck  

• Significance: Winrevair represents a paradigm shift in PAH treatment as the first FDA-approved activin signaling inhibitor therapy. Unlike traditional receptor agonists, it improves the balance between pro- and anti-proliferative signaling, regulating vascular cell proliferation in PAH. 

• Clinical Trial Results:  

  • Increased six-minute walk distance by 41 meters after 24 weeks 

  • Reduced risk of death by 84% when combined with standard care 

4. Vadadustat (Vafseo) 

• Approved: March 27, 2024 

• Indication: Symptomatic anemia in Chronic Kidney Disease (CKD) 

• Administration: Oral 

• Mechanism: Hypoxia-inducible factor prolyl-hydroxylase inhibitor 

• Developer: Akebia Therapeutics 

• Significance: Vafseo provides a new oral option for managing anemia in CKD patients, a common and challenging complication. 

• Notes:  

  • Approved after initial rejection two years prior based on safety data from Japan, where the drug had been used since 2020 

  • It can only be used in kidney disease patients on dialysis for at least 3 months. The label includes a “black box” warning for CV risk due to blood clots. 

Expanded FDA Approvals 

• Wegovy (Approved: 03/08/2024) Additional indication for cardiovascular risk reduction. These expanded approvals broaden treatment options across various patient populations, particularly in lipid management and cardiovascular risk reduction. 

• Praluent (alirocumab) (Approved: 03/11/2024) Extended to pediatric patients aged 8+ with heterozygous familial hypercholesterolemia (HeFH). 

• Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) (Approved: 03/22/2024)  

  • New indications for cardiovascular risk reduction and LDL-C reduction in primary and secondary prevention 

  • It can be used independently or with statins 

  • First non-statin drugs indicated for primary prevention patients 

April 2024 FDA Approvals: Advancing Structural Heart Interventions 

TriClip G4 System (Approved: 04/01/2024) This heart clip implant offers a minimally invasive approach to treating tricuspid regurgitation (leaky tricuspid valve) without open-heart surgery in eligible patients. 

June 2024 FDA Approvals: New Horizon in COPD Management 

Ensifentrine (Ohtuvayre) 

• Indication: Chronic Obstructive Pulmonary Disease (COPD) 

• Administration: Inhaled 

• Mechanism: Dual PDE3/4 inhibitor 

• Developer: Verona Pharma 

• Significance: The first novel MOA for COPD management in 20 years, complementing the class of inhaled mechanisms for COPD treatment. 

• Clinical Trial Results: 

  • Significantly improved lung function across trials. 

  • Well tolerated in both treatment groups. 

Looking Ahead

As we approach the second half of 2024, the cardiorenal metabolic treatment landscape continues to evolve rapidly. The CMHC faculty is monitoring potential drug and device approvals on the horizon, which will be presented at the upcoming 19th Annual CMHC (Oct. 17-19) in Boston, MA.

These approvals represent significant advancements in cardiorenal metabolic care, offering new hope for millions of patients worldwide. CMHC remains committed to providing the latest insights and medical education on these groundbreaking therapies.

Join us at the 19th Annual CMHC, where we’ll delve deeper into these innovations and their implications for clinical practice. Attendees can look forward to FDA updates, patient case studies, late-breaking trial data, and advancements in cardiorenal metabolic care. Don’t miss this opportunity to stay at the forefront of cardiorenal metabolic care and enhance your clinical practice.

Click here to learn more and register for the 19th Annual CMHC.