Hamdy Alkady: FDA Approves the First Oral PCSK9 Inhibitor
Hamdy Alkady, Consultant Endocrinologist at King Fahad Armed Forces Hospital, shared a post on LinkedIn about recent articles, adding:
“A New Era in Lipid Management Begins
The U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide), the first oral PCSK9 inhibitor, marking a major milestone in the treatment of hypercholesterolemia.
For years, PCSK9 inhibition has required injectable monoclonal antibodies.
Enlicitide now introduces a once-daily oral alternative, potentially expanding treatment options for patients who need substantial LDL-C reduction but prefer to avoid injections.
Key highlights from the Phase 3 CORALreef program:
LDL-C reduction of approximately 56–59% on top of background lipid-lowering therapy.
Significant reductions in:
- Non-HDL cholesterol
- Apolipoprotein B
- Lipoprotein(a)
Safety profile generally comparable to placebo, with mostly mild gastrointestinal adverse events.
What does this mean clinically?
This approval represents an important advance for patients with:
- Established atherosclerotic cardiovascular disease (ASCVD)
- Heterozygous familial hypercholesterolemia (HeFH)
- Persistent LDL-C elevation despite maximally tolerated statin therapy
However, it is important to note that approval is based on LDL-C lowering rather than cardiovascular outcomes.
The ongoing CORALreef Outcomes trial will determine whether enlicitide reduces myocardial infarction, stroke, and cardiovascular death.
If outcome benefits are confirmed, oral PCSK9 inhibition may become one of the most important developments in preventive cardiology over the coming years.
The era of injectable-only PCSK9 inhibition has officially expanded to include an oral option.”
Title: A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide
Authors: Ann Marie Navar, Elina Mikhailova, Alberico L Catapano, Puja Banka, Dirk J Blom, Alberto Cadena, Susan Kourpanidis, Norman E Lepor, Kazuhisa Tsukamoto, Geraldine Mendizabal, Julio Nunez, Wenjuan Zhang, Pengfei Zhu, Min Zhuo, Christie M Ballantyne
Title: Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial
Authors: Alberico L. Catapano, Elina Mikhailova, Ann Marie Navar, Puja Banka, Pablo Corral, Manish Saxena, P. Gabriel Steg, Subodh Verma, Andrew Yacoub Kordahi, Geraldine Mendizabal, Pengfei Zhu, Christie M. Ballantyne
Title: Efficacy and Safety of Oral PCSK9 Inhibitor Enlicitide in Adults With Heterozygous Familial Hypercholesterolemia: A Randomized Clinical Trial
Authors: Christie M. Ballantyne, Laura Gellis, Jean-Claude Tardif, Puja Banka, Ann Marie Navar, Emil Andreas Asprusten, Russell Scott, Erik S. G. Stroes, Samar Froman, Geraldine Mendizabal, Fan Wang, Alberico L. Catapano
Stay updated with Hemostasis Today.
-
Nov 9, 2026, 09:29Veronica Sanchez: A Framework for Woman’s Health
-
Nov 8, 2026, 19:31Anna Kajaste-Rudnitski: Presenting AAV-Induced p53 Signalling in Human CNS Cells at ESGCT 26
-
Nov 8, 2026, 19:29David McIntosh: Cybersecurity Matters, but Blood Availability Remains the Bigger Challenge
-
Nov 8, 2026, 19:26Wenxue Ma: An Integrative Framework for Macrophage-Mediated Therapeutic Resistance in Cancer
-
Nov 8, 2026, 19:25Yildiz Yigit: Presenting a Polycythemia Vera Case at the MPN Subcommittee Session
-
Nov 8, 2026, 18:56Denis Oduor: Strengthening the Regulation and Delivery of Blood Transfusion and Transplantation Services
-
Nov 8, 2026, 18:28Raghavendra Rao: A Narrative Review on Chronic Venous Disease during Pregnancy
-
Nov 8, 2026, 17:57Dhiren Patel: PLD1-Derived Phospholipids Regulate NAD Kinase and ROS Production in Neutrophils
-
Nov 8, 2026, 17:48Andra T.: What Causes Antiphospholipid Syndrome? – Four Steps, not One Cause