ABSTRACT
In 2022, the US Food and Drug Administration (FDA) approved 37 novel drugs. Twenty-four of the 37 (65%) novel drug approvals were reviewed and approved through an expedited review pathway and 20 of the 37 (54%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2022.
Subject(s)
Drug Approval , United States , Humans , Pharmaceutical Preparations , United States Food and Drug AdministrationABSTRACT
This study aimed to compare complete revascularization (CR) guided by angiography with a fractional flow reserve (FFR)-guided strategy in patients presenting with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD). CR is preferred to culprit-only revascularization for patients with STEMI and MVD. However, whether FFR-guided CR is superior to angiography-guided CR is unclear in patients presenting with STEMI who have MVD. Randomized controlled trials comparing CR with an FFR- or angiography-guided strategy to culprit-only revascularization in patients with STEMI and MVD were systematically identified. A random-effects network meta-analysis was performed comparing clinical outcomes in the 3 arms. A total of 13 studies with a total of 8,927 patients were included in our analysis. Compared with culprit-only revascularization, angiography-guided CR was associated with a significantly decreased risk of myocardial infarction (MI) (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.37 to 0.82), all-cause death (HR 0.69, 95% CI 0.49 to 0.97), and cardiovascular death (HR 0.54, 95% CI 0.34 to 0.85) but FFR-guided CR was not (MI: HR 0.77, 95% CI 0.53 to 1.12; cardiovascular death: HR 0.89, 95% CI 0.64 to 1.24; all-cause death: HR 0.93, 95% CI 0.72 to 1.18). The network meta-analysis comparison of angiography- versus FFR-guided CR showed an HR of 0.75 (95% CI 0.50 to 1.11) for all-cause death and an HR of 0.71 (95% CI 0.54 to 1.17) for MI. In conclusion, for patients with MVD presenting with STEMI, angiography-guided CR may provide additional benefits compared with FFR-guided CR.
Subject(s)
Coronary Artery Disease , Fractional Flow Reserve, Myocardial , Myocardial Infarction , Percutaneous Coronary Intervention , ST Elevation Myocardial Infarction , Arteries , Coronary Angiography , Coronary Artery Disease/complications , Humans , Myocardial Infarction/complications , Myocardial Infarction/diagnosis , Myocardial Infarction/surgery , Myocardial Revascularization , ST Elevation Myocardial Infarction/complications , ST Elevation Myocardial Infarction/diagnosis , ST Elevation Myocardial Infarction/surgery , Treatment OutcomeABSTRACT
In 2021, the US Food and Drug Administration (FDA) approved 50 novel drugs. Thirty-seven of the 50 (74%) novel drug approvals were reviewed and approved through an expedited review pathway, and 26 of the 50 (52%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the FDA in 2021.
Subject(s)
Drug Approval , Humans , Pharmaceutical Preparations , United States , United States Food and Drug AdministrationABSTRACT
In 2020, the US Food and Drug Administration approved 53 novel drugs. Thirty-six of the 53 (68%) drugs were reviewed and approved through an expedited review pathway, and 31 of the 53 (58%) were approved for treatment of a rare disease. This review includes a summary of the novel drugs approved by the US Food and Drug Administration in 2020.
