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Related Concept Videos

Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents01:29

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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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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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FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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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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Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide...
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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Related Experiment Video

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Assessment of Human Natural Killer Cell Events Driven by FcγRIIIa Engagement in the Presence of Therapeutic Antibodies
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Idarucizumab: First Global Approval.

Celeste B Burness1

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

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|November 19, 2015
PubMed
Summary

Idarucizumab is a new antidote that safely and effectively reverses the anticoagulant effects of dabigatran etexilate. This breakthrough offers critical options for patients needing urgent procedures or experiencing bleeding events.

Area of Science:

  • Pharmacology
  • Clinical Medicine
  • Drug Development

Background:

  • Dabigatran etexilate (Pradaxa®) is a direct oral thrombin inhibitor with anticoagulant properties.
  • Reversing dabigatran's effects is crucial for emergency surgery or life-threatening bleeding.
  • Existing reversal agents lack specificity for direct thrombin inhibitors.

Purpose of the Study:

  • To summarize the development of idarucizumab, a specific antidote for dabigatran etexilate.
  • To highlight the milestones leading to idarucizumab's first global approval.
  • To provide an overview of idarucizumab's role in reversing dabigatran's anticoagulant activity.

Main Methods:

  • Review of preclinical and clinical studies on idarucizumab.
  • Analysis of regulatory submission data and approvals.

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  • Summary of idarucizumab's mechanism of action and efficacy.

    • Main Results:

    • Idarucizumab, a monoclonal antibody fragment, specifically binds and neutralizes dabigatran.
    • First global approval in the USA in October 2015 for specific clinical scenarios.
    • Positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use.

    Conclusions:

    • Idarucizumab provides rapid and effective reversal of dabigatran's anticoagulant effect.
    • This specific antidote addresses a critical unmet need in managing dabigatran therapy.
    • Idarucizumab represents a significant advancement in anticoagulant reversal therapy.