Diana Ernst, RPh

Results from a phase 3 trial evaluating the efficacy of evinacumab in the treatment of patients with HoFH showed that the investigational ANGPTL3 antibody reduced LDL-C by 49%.

The FDA has approved a new sprinkle formulation of rosuvastatin, an HMG Co-A reductase inhibitor. 

The FDA has approved Katerzia, a ready-to-use, oral suspension formulation of amlodipine.

The FDA has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization in patients with chronic heart failure.

The FDA has accepted for Priority Review the supplemental BLA for Rituxan for use in combination with glucocorticoids for the treatment in pediatrics.

The FDA has accepted for Priority Review the supplemental New Drug Application for Vascepa.

The NLA has released updated guidance for clinicians on identifying patients for which PCSK9 inhibitor therapy would provide reasonable value.

The FDA has approved Fragmin a low molecular weight heparin, for the treatment of symptomatic venous thromboembolism.

The FDA has approved Vyndaqel and Vyndamax for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis.

The FDA has approved Praluent (alirocumab; Sanofi and Regeneron), a PCSK9 inhibitor, to reduce the risk of myocardial infarction (MI), stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.