Drugs

Merck’s Oral PCSK9 Candidate Cuts LDL by Up to 60%

Merck is reporting positive Phase 3 results for its oral PCSK9 inhibitor enlicitide, showing LDL-cholesterol reductions approaching 60% with a safety profile comparable to placebo. In the 2,900-patient study, adults with or at risk for atherosclerotic cardiovascular disease (ASCVD) taking once-daily enlicitide saw a 55.8% LDL-C reduction at week 24 versus placebo in the primary analysis, according to the company. A post-hoc reanalysis that removed five implausible baseline values showed a 59.7% drop.

LDL reductions remained durable through one year, Merck says, with declines of 47.6% (primary) and 52.4% (post-hoc). Enlicitide also reduced non-HDL-C, ApoB, and Lp(a), meeting all key secondary endpoints.

Safety results were largely indistinguishable from placebo, it says, with similar adverse event rates, serious events, and discontinuations (3.1% with enlicitide vs. 4.1% with placebo). Study adherence exceeded 97%, it adds.

Two-thirds of patients on enlicitide hit an aggressive combined goal: at least a 50% LDL reduction and an on-treatment LDL below 55 mg/dL at week 24. Only 1.2% of placebo patients met that bar.

“This drug delivered impressive LDL reductions with placebo-like safety,” a Merck release says. “Despite multiple available therapies, most ASCVD patients still don’t reach LDL targets. An oral PCSK9 inhibitor could be practice-changing.”

Enlicitide is described as a macrocyclic peptide designed to reproduce the biological mechanism of injectable PCSK9 monoclonal antibodies in a pill. If approved, it would become the first oral agent in the class.

Merck plans to submit data from CORALreef Lipids alongside two other pivotal programs — CORALreef HeFH and CORALreef AddOn — to regulators worldwide. The company is also running a 14,500-patient cardiovascular outcomes study, CORALreef Outcomes, which has completed enrollment.

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