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Top Cardiometabolic Pipeline News for 2022

With less than a week to go until the close of 2022, our editorial team is kicking off the final week of the year by recapping some of our most popular stories and content from the past year. Here, we are highlighting the most popular pipeline and regulatory news from the past year. For our readers, we’ve broken down this list into top trial news, approvals, and CRLs of note from 2022 in cardiometabolic health. Below, you will find a brief recap of each and links to any associated coverage.

Top Cardiology Pipeline News

Phase 3 Trial News:

DELIVER

Dapagliflozin Proves HFpEF Benefit in DELIVER Trial

Use of dapagliflozin (Farxiga) was associated with an 18% reduction in worsening heart failure or cardiovascular death among patients with heart failure with preserved ejection fraction, according to the results of the phase 3 DELIVER trial.

Presented less than 3 months after AstraZeneca announced the trial had met its primary endpoint back in May, results of the study build on the evidence from EMPEROR-Preserved and contribute to the idea that the benefits seen in HFpEF could be a class effect for SGLT2 inhibitors.

Related: 8-in-10 Medicare Beneficiaries Hospitalized with HFpEF Could be Considered Candidates for Dapagliflozin

Don't Miss a Beat: ESC Congress 22 Recap (See Preview Below)

EMPA-Kidney

Empagliflozin Significantly Reduces Risk of Kidney Disease Progression, Cardiovascular Disease Mortality (Coverage from HCPLive)

Data from the EMPA-KIDNEY trial, which was presented during the 2022 American Society of Nephrology Annual Meeting in Orlando, indicates empagliflozin (Jardiance) resulted in a significant reduction in kidney disease progression and cardiovascular disease mortality in patients with chronic kidney disease, regardless of diabetes status.

Related: Don't Miss a Beat: AHA 2022

CLEAR Outcomes

CLEAR Outcomes: Bempedoic Acid Reduces Cardiovascular Events

Nearly 3 years after approval from the US Food and Drug Administration for lowering LDL-C, data from the CLEAR Outcomes trial confirm bempedoic acid (NEXLETOL) use is associated with a statistically significant and clinically meaningful reduction in risk of major adverse cardiovascular events.

Announced in a December 7 statement from Esperion, the company expects to present comprehensive data at a medical conference in the first quarter of 2023 and suggests, with results, bempedoic acid becomes the first ATP citrate lyase inhibitor and first oral non-statin to meet the MACE-4 primary endpoint, which includes cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and unstable angina requiring hospitalization.

Related: Bempedoic Acid to Manage ASCVD and Hypercholesterolemia (Video)

Top Approvals:

Empagliflozin for the Entire Spectrum of Heart Failure

FDA Approves Empagliflozin for Treatment in Adults with Heart Failure

The US Food and Drug Administration has announced the approval of empagliflozin (Jardiance) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients.

With previous approvals for reducing risk of cardiovascular death in type 2 diabetes and reducing risk of death and hospitalization in HFrEF, the latest approval, which was announced in a press release from the FDA on February 24, is based on the results of the landmark EMPEROR-Preserved trial.

Related: Q&A on EMPEROR-Preserved With Javed Butler, MD

Mavacamten for oHCM

FDA Approves Mavacamten (Camzyos) for Obstructive Hypertrophic Cardiomyopathy

The US Food and Drug Administration (FDA) has approved mavacamten (Camzyos), granting the first-in-class agent an indication for improving functional capacity and symptoms in patients with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM), according to a release from Bristol Myers Squibb.

Announced on April 28, the approval is for treatment of adults with symptomatic NYHA class 2-3 obstructive HCM and is based on the results of EXPLORER-HCM trial, which found use of mavacamten was associated with improved exercise capacity, LVOT obstruction, NYHA functional class, and health status among patients with symptomatic obstructive HCM.

Related: Understanding the Mavacamten Approval: Perspective from an oHCM Specialist

CRLs of Note:

FDA Issues CRL for Vadadustat in Treatment of Anemia Due to CKD

Akebia Therapeutics has announced the US Food and Drug Administration have issued a Complete Response Letter for their New Drug Application for vadadustat for treatment of anemia due to chronic kidney disease in adult patients on dialysis and not on dialysis, according to a statement from the company.

An investigational oral hypoxia-inducible factor prolyl hydroxyls inhibitor, the FDA’s decision was based on data within the NDA not supporting a favorable risk-benefit assessment for vadadustat in dialysis and non-dialysis patients, with concern over the agent’s failure to meet noninferiority in major adverse cardiovascular events among the non-dialysis patients.

FDA Issues CRL for Bardoxolone Methyl in CKD Caused By Alport Syndrome

A bardoxolone methyl approval has been postponed indefinitely as the US Food and Drug Administration has issued a Complete Response Letter to Reata Pharmaceuticals, Inc. concerning their NDA for bardoxolone methyl as a treatment chronic kidney disease caused by Alport syndrome, according to a February 25 statement from the company.

The subject of a December 8, 2021, Cardiovascular and Renal Drugs Advisory Committee meeting where committee members voted unanimously against approval, Reata Pharmaceuticals stated the FDA concluded it did not believe the submitted data demonstrated bardoxolone’s ability to slow the loss of kidney function in patients with Alport syndrome and reducing the risk of progression to kidney failure. The statement from Reata Pharmaceuticals also noted additional data from the company was requested to support the efficacy and safety of bardoxolone.