Tag

Lipfendra

All articles tagged with #lipfendra

business25 days ago•4 min saved

Merck's Lipfendra Becomes the First Oral PCSK9 Inhibitor to Lower LDL-C

The FDA has approved Lipfendra (enlicitide), Merck’s oral PCSK9 inhibitor, to lower LDL-C in patients not adequately controlled on statins. As the first oral option in this class, enlicitide is a macrocyclic peptide designed to disrupt PCSK9-LDL receptor interactions and is produced via a biocatalytic process using 13 engineered enzymes. Because it’s a pill rather than an injectable antibody, it could be prescribed by general practitioners, expanding access, though cost and adherence remain concerns; patients must fast for 30 minutes after dosing for full absorption.

via Chemistry World|

#business #enlicitide #ldl-c

business26 days ago•4 min saved

Merck Eyes Blockbuster Potential with Lipfendra, the First Oral PCSK9 Drug

Merck is betting Lipfendra—the first oral PCSK9 inhibitor—will unlock a sluggish market after gaining July FDA approval via the Commissioner’s National Priority Voucher (CNPV) program, with initial demand rising but payer access likely slow; priced at $315 per month and supported by a direct-to-patient discount plan, Merck sees long-term blockbuster potential and is exploring combos with rosuvastatin and MK-7262, plus an outcomes study due in 2029.

via Fierce Pharma|

#business #cnpv #fda

cholesterol-and-cardiovascular27 days ago•29 min saved

Lipfendra: the first daily oral PCSK9 inhibitor and how it compares with statins

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor for high cholesterol and heterozygous familial hypercholesterolemia. In trials, Lipfendra lowered LDL cholesterol by about 56–59% versus placebo, mainly in patients already on statins, but there’s no head‑to‑head comparison with statins yet. It can be used alongside statins or other lipid drugs when LDL remains above goal, offering a pill alternative to injectable PCSK9 inhibitors. However, it’s approved only for adults, has a stringent morning-on-empty-stomach regimen, and more cardiovascular outcomes data are still being gathered, so doctors will tailor its use to patients who need additional LDL lowering beyond maximally tolerated statin therapy.

via Medical News Today|

#cholesterol #cholesterol-and-cardiovascular #ldl-cholesterol

business28 days ago•39 min saved

Merck Q2 2026 Highlights: Oncology Momentum, FDA Wins, and Terns Deal Reshapes Guidance

Merck posted 2Q26 sales of about $16.6B with KEYTRUDA/KEYTRUDA QLEX driving growth alongside WINREVAIR and Animal Health, while a $2.31 per-share charge tied to the Terns acquisition weighed on GAAP earnings and led to a narrowed full-year outlook of $66.3–$67.3B in sales and $2.66–$2.76 in non-GAAP EPS. The company highlighted FDA approvals for LIPFENDRA and several positive Phase 3 results across its oncology and HIV programs, plus continued progress across vaccines, immunology, and other pipeline milestones, including TroFuse-005 in endometrial cancer and ISL/LEN HIV regimens, as it advances its 2026 strategic plan.

via Merck.com|

#business #keytruda #lipfendra

health28 days ago•5 min saved

New Lipid Drugs and Updated Guidelines Expand Statin Eligibility, Redefining Cholesterol Care

Inclisiran lowers LDL by about 49% versus placebo in a meta-analysis and is a twice-yearly option that can be used with or without statins; Lipfendra (enlicitide), the first oral PCSK9 inhibitor, lowered LDL by roughly 56–59% in trials; combined with updated U.S. cholesterol guidelines that may make over half of adults eligible for statin therapy, these developments indicate a shift toward broader, personalized cholesterol management and adherence-friendly therapies.

via Healthline|

#cholesterol-guidelines #health #inclisiran

health1 month ago•3 min saved

Oral Lipfendra could redefine cholesterol management, doctors say

The FDA approved Lipfendra, an oral PCSK9 inhibitor, which when used with statins lowered LDL cholesterol by about 60% in a 24-week trial; doctors expect to prescribe it to a large share of patients with high cholesterol, potentially changing treatment for the roughly 86 million Americans affected. The pill costs about $315 per month and is seen as easier to manage than the injectable version, with side effects like dizziness and diarrhea similar to placebo in trials. Lowering cholesterol can promote plaque regression and reduce the risk of heart attack or stroke, especially when combined with lifestyle changes and statin therapy.

via The Spokesman-Review|

#cholesterol #fda-approval #health

health1 month ago•2 min saved

FDA approves first oral PCSK9 inhibitor to lower LDL cholesterol

The US FDA approved Lipfendra, the world’s first oral PCSK9 inhibitor, for adults with high cholesterol including heterozygous familial hypercholesterolaemia, offering an injectable-free option. In trials, it reduced LDL cholesterol by about 56–59% over 24 weeks in patients on maximally tolerated statins, with effectiveness comparable to injectable PCSK9 inhibitors. It is unlikely to be a first-line therapy, and it won’t be available in India immediately, as CDSCO clearance (and possibly local trials) would be required. Doctors say it could help patients who prefer oral treatment or struggle with injections.

via The Times of India|

#familial-hypercholesterolemia #fda-approval #health

health1 month ago•380 min saved

Merck's Lipfendra lands FDA nod as oral PCSK9 cholesterol fighter

The FDA approved Lipfendra, Merck's oral cholesterol-lowering drug that blocks the PCSK9 protein, offering a non-injectable option to reduce LDL cholesterol by up to about 60% after 24 weeks in trials. It targets hypercholesterolemia (including familial forms) for patients often already on statins, expanding treatment beyond injectable PCSK9 inhibitors. Lipfendra is priced at $10.50 per day (about $315 for a 30‑day supply), with Merck signaling lower out‑of‑pocket costs. The approval aligns with evolving guidelines urging aggressive LDL targets to cut heart-disease and stroke risk.

via NBC News|

#health #hypercholesterolemia #ldl-cholesterol

health1 month ago•5 min saved

FDA approves first oral PCSK9 inhibitor to slash LDL cholesterol

The FDA approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, to be used with diet and existing LDL-lowering therapies in adults with high cholesterol, including inherited forms. In phase 3 trials, Lipfendra reduced LDL cholesterol by about 56%–60% when added to statin therapy, roughly doubling the impact of many statin regimens. The pill offers a convenient alternative to injectable PCSK9 inhibitors and was generally well tolerated, with diarrhea and dizziness as common side effects and similar discontinuation rates to placebo. Merck noted that large cardiovascular-outcome data are still pending, with results expected in 2029.

via Fox News|

#cholesterol #fda-approval #health

health1 month ago•192 min saved

Merck’s Lipfendra gains FDA nod as first oral PCSK9 inhibitor

Merck’s cholesterol pill Lipfendra (enlicitide) was approved by the FDA, becoming the first oral PCSK9 inhibitor on the market and offering an alternative to injectable cholesterol drugs. The decision was based on two late‑stage trials showing significant LDL‑C reductions across a broad patient group, including those with familial hypercholesterolemia and statin users. The drug could help Merck diversify beyond Keytruda, with analysts forecasting potential tens of billions in peak sales amid competition from injectable PCSK9 drugs like Repatha and Praluent.

via CNN|

#enlicitide #fda #health