NOVARTIS
Inclisiran showed high consistency in lowering LDL-C levels in adults
Novartis announced the posthoc analysis data of Phase 3 ORION-10 and ORION-11 clinical trials. The study was intended to evaluate the reduction in low-density lipoprotein cholesterol (LDL-C) on administration inclisiran.
The results demonstrated that 99% of patients who were on inclisiran showed a placebo-adjusted ≥30% reduction in LDL-C levels with a mean reduction of 54.1%. Further, after 17 months of treatment, 66.4% of patients who were on the inclisiran group had a reduction in LDL-C of at least 50% compared to 2.5% in the placebo group.
Patients were administered inclisiran twice years, following initiation dose and another dose three months later.
The drug is currently under review for treating primary hyperlipidemia (including Heterozygous Familial Hypercholesterolemia) by the U.S. Food and Drug Administration and European Medicines Agency.
ELI LILLY
Jardiance decreased the risk of cardiovascular death and hospitalization by 25% in patients who had heart failure with a reduced ejection fraction
Eli Lilly has presented the phase III EMPEROR data of Jardiance (empagliflozin) in adult patients with heart failure with reduced ejection fraction. Patients with both diabetes mellitus and without diabetes mellitus have been considered for the study.
The primary endpoint considered was time to cardiovascular death or hospitalization due to heart failure; the risk of the primary endpoint was reduced by 25% in Jardiance arm. The trial compared Jardiance with a placebo plus standard of care. The risk of first and recurrent hospitalization for heart failure, which was a key secondary endpoint, was decreased by 30%.
Eli Lilly has announced that in EMPEROR-Reduced study, the results were achieved with a single dosage regimen, and there was no need for titrations.
AMGEN
Amgen to present the data of Repatha
Amgen has announced that it will present the data of Repatha® (evolocumab) in high-risk patients. The company announced that it would present the Phase 3 clinical trial demonstrating the efficacy of Repatha in Pediatric Heterozygous Familial Hypercholesterolemia.
ASTRAZENECA
Farxiga demonstrated a significant reduction in kidney failure and cardiovascular or renal death in CKD patients
AstraZeneca has announced that treating chronic kidney failure patients with Farxiga (dapagliflozin) resulted in the reduction in the risk of kidney failure and cardiovascular or renal death.
The company has presented the clinical trial data of the Phase III DAPA-CKD trial, in which Farxiga reduced the risk of cardiovascular or renal death by 39% compared to placebo. Patients with chronic kidney disease Stages 2-4 and elevated urinary albumin excretion were included in the study.
DAPA-CKD trial is a Phase 3, multicentre, randomized, double-blind, placebo-controlled study which enrolled 4,304 patients. Time to the first occurrence of any of the components of the composite (≥50% sustained decline in eGFR or reaching ESRD or CV death or renal death) was considered as the primary endpoint. The absolute risk of reduction was 5.3% over a period of 2.4 years (median time).
The results were consistent in both diabetes and non-diabetes patients.
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