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Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
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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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Area of Science:

  • Immunology
  • Virology
  • Pharmacology

Background:

  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes COVID-19.
  • Effective treatments are crucial for managing COVID-19, particularly for high-risk individuals.
  • Monoclonal antibodies offer a targeted therapeutic approach against viral infections.

Purpose of the Study:

  • To summarize the development milestones of sotrovimab.
  • To highlight the regulatory pathway leading to its first full approval.
  • To document the initial regulatory authorizations for sotrovimab.

Main Methods:

  • Review of development and regulatory submission data for sotrovimab.
  • Analysis of clinical trial outcomes supporting efficacy and safety.
  • Tracking of emergency use and full approval timelines across different regions.

Main Results:

  • Sotrovimab, a monoclonal antibody, targets SARS-CoV-2.
  • Received initial emergency use authorization in the USA in May 2021.
  • Achieved first full European Union approval in December 2021 for specific patient groups.

Conclusions:

  • Sotrovimab development has progressed through key regulatory milestones.
  • Full EU approval signifies a significant advancement in COVID-19 treatment options.
  • The antibody is indicated for high-risk adolescents and adults with COVID-19 not requiring oxygen.