Pfizer Ends Development of Vupanorsen Over Disappointing Results, Safety Issues
The decision was made based on data from a phase 2b study that evaluated vupanorsen in statin-treated patients with dyslipidemia.
Dyslipidemia
Leqvio Approved as Twice-Yearly Injection to Lower LDL-C in High-Risk Patients
The approval was based on data from the ORION-9, ORION-10, and ORION-11 trials that evaluated Leqvio in patients 18 years of age and older with HeFH or clinical ASCVD.
LDL-C Reduction Observed With Inclisiran Regardless of BMI
Inclisiran is a chemically synthesized small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA.
Repatha Approved for Younger Patients with HeFH and HoFH
The approval of Repatha was also expanded to include patients 10 years of age and older with HoFH.
Cholesterol Management Supplement Found to Contain Undeclared Rx Ingredient
Cholestene, a dietary supplement marketed for cholesterol management, has been found to contain a hidden drug ingredient, according to the Food and Drug Administration. Based on laboratory analysis, the product, which is sold on various websites and in some retail stores, has been found to contain lovastatin, an HMG-CoA reductase inhibitor (statin). Consuming a supplement…
Praluent Approved for Homozygous Familial Hypercholesterolemia
The approval was based on data from the phase 3 ODYSSEY HoFH trial, which evaluated Praluent in 69 adults with HoFH who were on other LDL-C-lowering therapies.
Aspirin Overused, Statins Underused for CVD Prevention in Seniors
56.4 percent aged 75 years and older using statin for secondary cardiovascular event prevention; 45.3 percent taking aspirin for primary prevention
Evkeeza Approved for Homozygous Familial Hypercholesterolemia
The approval was based on data from the double-blind, placebo-controlled phase 3 ELIPSE HoFH trial.
Inclisiran Approval Held Up by Inspection-Related Issues
Inclisiran is a chemically synthesized small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA.
Evolocumab Cuts LDL-C in Pediatric HeFH Patients
The multicenter, double-blind, placebo-controlled HAUSER-RCT study assessed the efficacy and safety of evolocumab in 157 patients aged 10 to 17 years with HeFH.
