Drugs

Merck Reports Positive Data for PCSK9 Inhibitor Enlicitide

Merck is announcing promising topline results from two Phase 3 clinical trials evaluating investigational enlicitide decanoate, an oral PCSK9 inhibitor for use in adults with hyperlipidemia already on statin therapy. The trials — CORALreef HeFH and CORALreef AddOn — met all primary and key secondary endpoints, showing significant reductions in low-density lipoprotein cholesterol (LDL-C), according to the company. If its NDA is approved, enlicitide would be the first oral PCSK9 inhibitor available in the U.S., offering an alternative to current injectable therapies in a once-daily pill form.

Merck highlighted the following about each trial:

In the CORALreef HeFH trial, enlicitide significantly lowered LDL-C levels compared to placebo in patients with heterozygous familial hypercholesterolemia (HeFH) who were already receiving statins and were at risk for or had a history of atherosclerotic cardiovascular disease (ASCVD).
The CORALreef AddOn trial found that enlicitide outperformed ezetimibe, bempedoic acid, and the combination of both in reducing LDL-C in broader hyperlipidemic populations also on statins.

The company says the safety profiles in both trials were favorable, with no meaningful differences in adverse events or serious adverse events between treatment and control groups.

Merck describes enlicitide as a novel macrocyclic peptide designed to inhibit PCSK9, a protein that regulates LDL receptors. By blocking this interaction, enlicitide increases the number of LDL receptors available to clear cholesterol from the bloodstream, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome