Presentation (CTI)

OBJECTIVES: Approximately 20% of all deaths in the United States in 2022 were attributed to heart disease. Although cardiovascular disease remains a significant health burden, innovation in the field of cardiovascular drug development and approval has markedly decreased in recent decades. We assessed the trends in FDA approvals for cardiovascular medicines over a 45-year period from 1980 to 2024.
METHODS: We collected information for new molecular entities (NME) and new therapeutic biologics cardiovascular drugs approved by the FDA between 1980 and 2024 via publicly available data from the FDA database, Orange Book, and Purple Book. Data were analyzed using descriptive analysis.
RESULTS: A total of 123 drugs were approved during 1980-2024,102 (82.9%) remain marketed, and 21 (17.1%) were discontinued as of December 31, 2024. NMEs represented 119 (96.7%) and BLA had 4 (3.3%) cardiovascular drug approvals. There were 34 (27.6%) cardiovascular drugs classified as first-in-class, 40 (32.1%) underwent fast-track review to expedite availability, 3 (2.4%) breakthrough therapy designation. There were 17 (13.8 %) drugs that received orphan drug designation at first approval. The highest number of approvals occurred between 1980-1989. Cardiovascular drug approvals declined from an average of 4.0±3.3 from 1980-1989 to 1.3±0.7 from 2020-2024. Cardiovascular drugs represented 6.9% of the total new drug approvals in the study period.
CONCLUSIONS: Most cardiovascular drugs approved by the FDA from 1980-2024 did not represent an improvement over the therapies already available in the market, with only three new drugs designated by the FDA with breakthrough therapy designation. The highest number of approvals occurred between 1980 and 1989; the analysis shows a decline in cardiovascular drug approvals over the study period. Innovation in cardiovascular drug development remains critical to addressing unmet medical needs in this therapeutic area.