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Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF01:24

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Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
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Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
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Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
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Recaticimab: First Approval.

Yvette N Lamb1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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Summary
This summary is machine-generated.

Recaticimab, a novel antibody targeting PCSK9, has gained its first approval in China for treating hypercholesterolemia and mixed dyslipidemia. This marks a significant advancement in lipid-lowering therapies for patients unresponsive to statins.

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Area of Science:

  • Cardiovascular Pharmacology
  • Immunology
  • Drug Development

Background:

  • Hypercholesterolemia and mixed dyslipidemia are significant risk factors for cardiovascular disease.
  • Current lipid-lowering therapies, including statins, do not achieve target low-density lipoprotein cholesterol (LDL-C) levels in all patients.
  • Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a key regulator of LDL-C metabolism.

Purpose of the Study:

  • To summarize the development milestones of recaticimab, a humanized monoclonal antibody targeting PCSK9.
  • To highlight the regulatory approval of recaticimab for hypercholesterolemia and mixed dyslipidemia.

Main Methods:

  • Recaticimab is a humanized monoclonal immunoglobulin G1 antibody.
  • It targets PCSK9, inhibiting its interaction with the LDL receptor.
  • Development involved preclinical and clinical studies (details not provided in abstract).

Main Results:

  • Recaticimab received its first approval in China on January 8, 2025.
  • Approved as an adjunct to diet and statins for primary hypercholesterolemia and mixed dyslipidemia in adults not meeting LDL-C targets.
  • Approved as monotherapy for non-familial hypercholesterolemia and mixed dyslipidemia to reduce LDL-C, total cholesterol, and apolipoprotein B.

Conclusions:

  • Recaticimab represents a new therapeutic option for managing hypercholesterolemia and mixed dyslipidemia.
  • The approval signifies a milestone in the development of PCSK9 inhibitors.
  • This advancement offers a new strategy for patients requiring additional lipid-lowering therapy.