EMA panel recommends marketing oral semaglutide for T2D

  • European Medicines Agency

  • curated by Miriam Tucker
  • Clinical Essentials
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Takeaway

  • The European Medicines Agency’s (EMA's) human medicines committee (CHMP) has recommended marketing authorization in the European Union (EU) for an oral formulation of semaglutide for treating adults with insufficiently controlled type 2 diabetes (T2D).

Why this matters

  • Injectable formulations present a barrier to use for some patients.

Other key information

  • The oral semaglutide formulation works the same way as the injectable glucagon-like peptide-1 (GLP-1) receptor agonist: it reduces blood glucose by stimulating pancreatic insulin secretion and reducing glucagon secretion.
  • Safety and efficacy were studied in 8 clinical trials enrolling patients at various T2D stages:
    • Studies compared oral semaglutide with placebo, either as monotherapy or added to standard treatment, or compared it with injectable GLP-1 receptor agonists.
  • The most common side effects during the clinical trials were gastrointestinal, including nausea and diarrhea.
  • Hypoglycemia may occur when used in combination with insulin or sulfonylurea.
  • The CHMP opinion will now go to the European Commission for adoption of a decision on an EU-wide marketing authorization.
  • Once marketing authorization is granted, decisions about price and reimbursement will take place at the individual member state level.
  • Oral semaglutide was approved by FDA in September 2019.