Cardiology Month in Review: March 2024
Although it came on the heels of American Heart Month, March 2024 made a case for itself as the most important month of 2024 for cardiovascular health just 3 months into the new year. This is because March 2024 featured a barrage of news and data with immediate impact on the real-world care of patients considered at risk or with a history of cardiovascular disease, with 5 historic approvals in just 31 days.
In our cardiology month in review for March 2024, we recap these historic decisions, pipeline news from novel agents and familiar faces, and the latest scientific statement from the Heart Failure Society of America.
FDA News in Cardiology
As mentioned above, the month of March was defined by historic regulatory decisions in the world of cardiology. In this section of our month in review, we will spotlight 6 decisions making headlines during the past month.
FDA Approves AGENT DCB for In-Stent Restenosis
On March 01, 2024, Boston Scientific announced the AGENT had received FDA approval for the treatment of coronary in-stent restenosis in patient with coronary artery disease based on data from the AGENT IDE trial.
Marketed as the as the first coronary drug-coated balloon in the US to provide safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence, a 12-month interim analysis of the pivotal trial demonstrated use was associated with a statistically significant improvement in rate of target lesion failure at 12 months compared to uncoated balloon angioplasty (17.9% vs. 28.7%; P = .006).
Semaglutide Receives FDA Label Expansion to Include Cardiovascular Risk Reduction
Although no PDUFA date was publicly announced, a label expansion for cardiovascular risk reduction for semaglutide 2.4 mg (Wegovy) was a foregone conclusion to many following results of the SELECT trial. However, the field was unaware what the label expansion would entail.
This question was answered on March 08, 2024, when the FDA announced it had a approved a label expansion indicating the GLP-1 receptor agonist reducing the risk of cardiovascular death, heart attack, and stroke in adults with cardiovascular disease and obesity or overweight. The approval marked the first time in agency history it had approved a treatment for reducing cardiovascular risk specifically for patients with overweight or obesity.
Alirocumab Approved for Heterozygous Familial Hypercholesterolemia in Patients 8 Years and Older
Regeneron Pharmaceuticals announced the FDA approval of alirocumab (Praluent) as an adjunct to diet and other LDL-C lowering therapies for treatment of heterozygous familial hypercholesterolemia in pediatric patients aged 8 years and older on March 11, 2024. The latest approval, which occurred nearly a decade after the agent became the first PCSK9 inhibitor approved by the FDA, is based on data from a 24-week, phase 3 trial of 153 pediatric patients with HeFH inadequately controlled by statin therapy.
FDA Approves Aprocitentan for Treatment-Resistant Hypertension
On March 20, 2024,Idorsia Ltd. announced the FDA approved aprocitentan (Tryvio) for treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. The approval marked the first for an oral antihypertensive agent with a new mechanism of action in more than 30 years and was based on data from the phase 3 PRECISION trial
The decision comes more than a year after initial filing of the New Drug Application in December 2022 and just more than 6 months after Idorsia reacquired the world-wide rights to the oral, dual endothelin receptor antagonist back from with Johnson & Johnson's Janssen Biotech unit in September 2023.
Related: What to Know about the Aprocitentan Approval for Resistant Hypertension, with Michael Weber, MD
Bempedoic Acid Wins FDA Approval for Reducing Cardiovascular Risk in Primary, Secondary Prevention
On March 22, 2024, Esperion announced the FDA approved label expansions for bempedoic acid (Nexletol) and bempedoic acid with ezetimibe (Nexlizet) to include primary and secondary prevention of cardiovascular risk.
According to Esperion, the FDA’s decision makes bempedoic acid the first LDL-lowering non-statin agent to receive a primary prevention indication. Based on data from the CLEAR Outcomes trial, the new indications expand the potential patient population for the agent to approximately 70 million in the US.
FDA Approves Single-Tablet Macitentan, Tadalafil Combination for Pulmonary Arterial Hypertension
The FDA approved a single-tablet combination of macitentan and tadalafil (Opsynvi) for the chronic treatment of adults with pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) and WHO functional class (FC) II-III on March 22, 2024.
Announced by Johnson & Johnson, the approval marks the first single-tablet combination therapy for patients with PAH and is based in data from the phase 3 A DUE study.
Related Content: Recapping Q1 2024 FDA Decisions in Cardiology, with Deepak Bhatt, MD, MPH, MBA
Pipeline News in Cardiometabolic Health
Semaglutide 1.0 mg Reduced Kidney Events 24% in FLOW Trial
A label expansion for the 2.4 mg dose was not the only headlining news for semaglutide during the month of March, as Novo Nordisk announced topline data from the FLOW trial on March 05, 2024. The trial, which examines use of semaglutide 1.0 mg (Ozempic) for kidney outcomes in people with type 2 diabetes, was stopped early due to efficacy and topline results indicate use was associated with a 24% reduction in risk of kidney disease-related events relative to placebo therapy.
Full results of the trial are expected at the upcoming European Renal Association meeting in May 2024.
Related Content:Diabetes Dialogue: FLOW Trial and Chronic Kidney Disease Updates, with Brendon Neuen, MBBS, PhD
KARDIA-2: Zilebesiran Reduces Blood Pressure in Addition to Standard of Care
On March 05, 2024, the cardiology community received its latest insight into the effects of zilebesiran, an investigational RNAi therapeutic from Alnylam Pharmaceuticals, on hypertension in the form of topline results from the KARDIA-2 trial.
A phase 2 trial with more than 650 patients, KARDIA-2 evaluated the efficacy and safety of zilebesiran added to standard-of-care antihypertensives in adults with mild-to-moderate hypertension. Topline results from the trial indicated use was associated with statistically significant reductions in 24-hour mean systolic blood pressure at 3 months.
HFSA Calls Attention to Cognitive Impairment in Scientific Statement
The Role of Screening, Addressing Cognitive Impairment in Heart Failure Management
On March 12, 2024, the HFSA published a 17-page document taking aim at the prevalence and impact of cognitive impairment on management of heart failure. The document is divided into 5 sections addressing risk factors for cognitive impairment, implications of cognitive impairment, management of cognitive impairment, integration of cognitive impairment into decision-making, and gaps in knowledge and challenges to implementation.
Following release of the statement, HCPLive hosted a peer-to-peer discussion with the statements lead co-authors, Eiran Gorodeski, MD, MPH, and Parag Goyal, MD, MS, along with HFSA president James Fang, MD. In the discussion, the trio touch upon key takeaways, the complexities of heart failure management in patients with cognitive impairment, and the role of the Heart Failure Society of America and other professional organizations in aiding clinicians with incorporating changes and recommendations within these types of documents.
