Pharmaceutics

This page contains key pharmaceutical news on drug recalls, FDA clearance, safety communications and research. In cardiology, key pharmaceutic agents include antiplatelet therapies, anticoagulants, hypertension drugs, and drugs for heart failure and arrhythmias.   

FDA approves sotagliflozin, the new heart failure drug from Lexicon Pharmaceuticals

The drug, which should be available by the end of June, will be marketed under the name Inpefa.

FDA grants fast track designation to Bayer’s new drug for preventing stroke in AFib patients

The new drug, asundexian, is currently the subject of two multicenter Phase III studies—the OCEANIC-AF trial and OCEANIC-STROKE trial—focused on its safety and efficacy.

FDA expands dapagliflozin approval to cover all heart failure patients

The FDA has previously approved the SGLT2 inhibitor in patients with HFrEF, but not HFmrEF or HFpEF

Paul M. Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention, and the Eugene Braunwald Professor of Medicine, cardiovascular medicine, Brigham and Women's Hospital, who presented the results of late-breaking study on residual inflammatory risk in contemporary statin treated patients. The study used an analyses of 31,197 patients in the PROMINENT, REDUCE-IT and STRENGTH trials. 

What new data can teach cardiologists about statin use and treating inflammation

"If we do not attack the inflammation, we just are not going to get the best outcomes for our patients," one researcher told Cardiovascular Business. 

Marielle Scherrer Crosbie and Tomas Neilan explain the STOP-CA trial and how statins can help prevent cardiotoxicity from anthracycline chemo agents.

Statins may help prevent anthracycline cardiotoxicity in chemotherapy

The STOP-CA trial showed that statins can help chemotherapy patients avoid potential side effects related to anthracycline agents. Co-principal investigators Marielle Scherrer-Crosbie, MD, and Tomas Neilan, MD, discussed the details of that trial at ACC.23. 

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Clopidogrel linked to better long-term outcomes than aspirin in PCI patients with and without diabetes

Clopidogrel is especially effective at limiting major adverse cardiovascular events among PCI patients with diabetes, researchers found. 

Antibiotic recalled due to risk of endocarditis, other life-threatening infections

According to an advisory on the FDA’s website, there is a “reasonable probability” that any immunocompromised patients exposed to the affected antibiotic could develop a life-threatening infection.

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FDA approves drug for children with rare condition causing high LDL cholesterol

Evkeeza, which was previously approved for patients ages 12 and above, was shown to help lower cholesterol for children with homozygous familial hypercholesterolemia (HoFH), in conjunction with other therapies.