A field regarded for its innovation and advancement, it is rare a month goes by without news of major breakthroughs or regulatory decision. June was no exception, with major news or data releases coming throughout the month, including a trio of approvals from the US Food and Drug Administration and new data from the CLEAR Outcomes trial. In our month in review, we highlight the top 5 pieces of content from the month of June.

FDA Decisions

FDA Approves Ferric Carboxymaltose Injection for Iron Deficiency in Heart Failure

On June 5, 2023, the FDA approved ferric carboxymaltose injection (INJECTAFER®) for the treatment of iron deficiency in adult patients with New York Heat Association Class II-III heart failure, marking the first and only intravenous iron replacement therapy for this indication.

Announced in a release by Daiichi Sankyo, Inc. and American Regent, Inc., the approval was supported by data from the randomized, controlled CONFIRM-HF trial, which showed the therapy significantly improved exercise capacity compared to placebo in iron-deficient patients with heart failure.

FDA Approves Updated Label for Mavacamten in Obstructive Hypertrophic Cardiomyopathy

On June 15, 2023, Bristol Myers Squibb announced the FDA approved an updated label for mavacamten (Camzyos) to reflect the agent's ability to reduce the need or eligibility for septal reduction therapy in patients with obstructive HCM based on VALOR-HCM. the updated label, which covers the 2.5 mg, 5 mg, 10 mg, and 15 mg capsules, will reflect the reduction in guideline-based eligibility for SRT at week 16 or decision to decision to proceed with SRT prior to or at Week 16 associated with use of mavacamten in VALOR-HCM, according to the statement from Bristol Myers Squibb.

FDA Approves Colchicine Tablets for Reducing Cardiovascular Risk

On June 20, 2023, the cardiology community welcomed a historic approval, with the FDA awarding its first approval in agency history anti-inflammatory atheroprotective cardiovascular treatment. The approval of colchicine 0.5 mg tablets (Lodoco) for reducing the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease was awarded to AGEPHA Pharma USA and is supported by data from the LoDoCo2 trial.

Highlighting New Data

In addition to the aforementioned FDA approvals, our month in review for June 2023 also features a pair of studies highlighting new insights from major trial data, which were both among our most popular stories for month. The first study highlights the potential benefit of SGLT2 inhibitor class across multiple patient populations and, the next study, provides additional perspective into the CLEAR Outcomes trial and the role of bempedoic acid.

SGLT2 Inhibitors Benefit CV Outcomes Across Heart Failure, T2D, CKD Populations

In what investigators suggest should be a “call to action”, a meta-analysis of 13 trials including more than 90,000 patients published in the Journal of the American College of Cardiology offers the community a comprehensive overview of the cardiovascular benefits of SGLT2 inhibitor use in populations with heart failure,type 2 diabetes, and chronic kidney disease (CKD), as well as different combinations of these 3 diseases. led by Javed Butler, MD, from Baylor Scott and White Research Institute, reduced the risk of first heart failure hospitalization and/or cardiovascular death by 24% in heart failure (HR, 0.76; 95% CI, 0.72 - 0.81), 23% in type 2 diabetes (HR, 0.77; 95% CI, 0.73 - 0.81), and 23% in CKD (HR, 0.77%; 95% CI, 0.72 - 0.82).

Study Suggests Bempedoic Acid Could Find Role in Primary Prevention

New research presented at ADA 2023 suggests bempedoic acid could prove useful in a primary prevention role for people with statin intolerance. A subgroup analysis of a primary prevention cohort within the CLEAR Outcomes trial, results of the study, which come less than 4 months after the initial presentation of the trial ACC 2023, suggest use of bempedoic acid was associated with a 30% reduction in relative risk of a primary endpoint event in adjusted analyses during a median follow-up of 39.9 months (aHR, 0.70; 95% CI, 0.55-0.89; P = .002).