Drugs

Merck’s Oral PCSK9 Candidate Cuts LDL Cholesterol in Late-Stage Trial

Merck says new Phase 3 data show its investigational cholesterol drug enlicitide significantly lowered “bad” cholesterol compared with commonly used non-statin pills, positioning the therapy as a potential oral alternative to injectable PCSK9 inhibitors. Results from the CORALreef AddOn trial, presented at the American College of Cardiology Annual Scientific Session and published in the Journal of the American College of Cardiology, found that enlicitide reduced low-density lipoprotein cholesterol (LDL-C) by 64.6% from baseline at eight weeks when added to statins in patients with hypercholesterolemia at risk for cardiovascular disease.

Merck says the study compared enlicitide against three oral non-statin regimens: bempedoic acid, ezetimibe, and a combination of the two. Enlicitide demonstrated statistically significant superiority across all comparisons, reducing LDL-C by an additional 56.7% versus bempedoic acid, 36.0% versus ezetimibe, and 28.1% versus the combination therapy.

Researchers also reported higher rates of patients reaching guideline-recommended cholesterol targets. More than 78% of patients receiving enlicitide achieved at least a 50% LDL-C reduction and levels below 55 mg/dL, compared with 2% to 20% across the comparator groups.

“These results reinforce the practice-changing potential of an oral PCSK9 inhibitor,” said Alberico Catapano, a study author and professor at the University of Milan, noting that a majority of high-risk patients fail to meet cholesterol goals with existing therapies.

Safety outcomes were consistent with earlier studies, with no serious adverse events or treatment discontinuations attributed to enlicitide, according to Merck. Patient adherence exceeded 96% across all treatment groups.

Enlicitide is a once-daily oral therapy designed to inhibit PCSK9, a protein that regulates LDL receptor activity. Current drugs in this class are monoclonal antibody injections, and an effective pill could expand access and adherence.

The company notes that FDA granted enlicitide a Commissioner’s National Priority Voucher in December, potentially accelerating its review.

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