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The first half of 2022 has seen its fair share of FDA decisions, both approvals and CRLs. In this article, we recap the top regulatory events in cardiorenal metabolic health from the first half of the year, including news related to empagliflozin, mavacamten, and more.
After a busy Q4 and second half of 2021 for the US Food and Drug Administration (FDA), the cardiology community looked ahead with excitement towards 2022 and potential regulatory decisions to come. With noteworthy approvals including those awarded to evolocumab for HeFH, rivaroxaban receiving 2 new pediatric indications, and inclisiran’s approval for lowering LDL-C in ASCVD, the FDA made headlines throughout the second half of the year.
Although it has not been the benefactor of the sheer number of approvals as the preceding year, the first half of 2022 has seen its fair share of historic FDA decisions in cardiovascular medicine. From the issuance of Complete Response Letters (CRLs) for multiple therapies due to facility inspection issues to landmark approvals, the first 6 months of 2022 have been historic in its own right. In this listicle, we will be recapping our most popular content related to FDA decisions in cardiometabolic health to occur within the first 6 months of 2022.
Bristol Myers Squibb announced the FDA's approval of mavacamten for symptomatic obstructive hypertrophic cardiomyopathy in a press release on April 28. The specific indication from the FDA 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 coverage: Don’t Miss a Beat hosts Steve Greene, MD, and Muthiah Vaduganathan, MD, MPH, sat down with Anjali Owens, MD, of Penn Medicine, to discuss the approval of mavacamten and the current state of management for oHCM for a recent episode.
The Food and Drug Administration announced the approval of empagliflozin (Jardiance) for reducing risk of cardiovascular death and hospitalization for heart failure in adult patients in a press release on Feb. 24. With previous approvals, including an indication for reducing the risk of death and hospitalization in panthers with heart failure and low ejection fraction, the latest indication further expands the potential patient population for empagliflozin and is based on the results of the landmark EMPEROR-Preserved trial, which found use of empagliflozin was associated with a 9% reduction in risk of cardiovascular death and a 27% reduction in risk of heart failure hospitalization compared with placebo therapy.
Related coverage: Ahead of the American College of Cardiology (ACC) 2022 Annual Scientific Sessions, the ACC/AHA/HFSA released joint heart failure guidelines, which included new recommendations for SGLT2 inhibitor use in HFpEF. Additionally, Don’t Miss a Beat tackled these new guidelines and what the recommendations in HFpEF mean for clinicians and patients.
Abbott announced the FDA had approved an expanded indication for the CardioMEMS HF System in a press release on Feb. 21. With a prior indication awarded to the system in 2014 for the use in patients with NYHA Class III heart failure with prior heart failure hospitalization within the past year, the most recent approval indicates the system for use in patients with NYHA Class II heart failure and for patients who undergo a blood test showing elevated levels of biomarkers known as natriuretic peptides. Based on data from the GUIDE-HF trial, the approval expanded the potential patient population for the CardioMEMS HF System by 1.2 million additional US patients.
Medtronic announced the FDA had granted approval to the Onyx Frontier drug-eluting stent (DES) for treatment of patients with coronary artery disease in a press release on May 13. In their release, Medtronic noted the Onyx Frontier will be available in 2.0 mm sizes as well as 4.50-5.00 mm sizes that can be expanded to 6.00 mm. According to Medtronic, the Onyx Frontier DES uses the same stent platform as the Resolute Onyx DES, but is designed with multiple changes, including increased catheter flexibility, an innovative dual-layer balloon technology, and a lower crossing profile.
Reata Pharmaceuticals announced the FDA had issued a CRL to the company concerning their NDA for bardoxolone methyl as a treatment for chronic kidney disease (CKD) caused by Alport syndrome in a press release on Feb. 25. The issuance of the CRL follows a December 8, 2021 Cardiovascular and Renal Drugs Advisory Committee meeting where committee members voted unanimously against approval. According to Reata Pharmaceuticals, the FDA concluded it did not believe the submitted data demonstrated bardoxolone methyl’s ability to slow the loss of kidney function in patients with Alport Syndrome.
Akebia Therapeutics announced the FDA had issued CRL to the company for vadadustat as a treatment for anemia due to chronic kidney dialysis in adult patients on dialysis and not on dialysis in a press release on March 30. According to Akebia Therapeutics, the FDA’s decision was based on their perspective that the data within the NDA did not support a favorable risk-benefit assessment for the investigational oral hypoxia-inducible factor prolyl hydroxyls inhibitor, in dialysis and nondialysis patients, citing specific concerns over the agent’s failure to meet noninferiority in major adverse cardiovascular events among the nondialysis patients.