FDA approves first oral GLP-1 agonist for T2D

  • U.S. Food and Drug Administration
  • 20/09/2019

  • Craig Hicks
  • Clinical Essentials
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Takeaway

  • The FDA has approved semaglutide (Rybelsus) once-daily tablets to control blood sugar in adults with type 2 diabetes (T2D); it is the first glucagon-like peptide (GLP-1) receptor protein treatment approved by the agency that does not need to be injected.
  • Prescribing information.

Why this matters

  • The manufacturer describes semaglutide as the only GLP-1 analog in a pill and a new option for adults with T2D who are not achieving their A1C goals with current antidiabetic treatment.
  • Semaglutide was previously available as an injection (Ozempic).

Study design

  • Approval was based on data from PIONEER clinical trials of semaglutide alone and in combination with metformin, sulfonylureas, sodium-glucose co-transporter-2 (SGLT-2) inhibitors, insulins, and thiazolidinediones,
  • Funding: Novo Nordisk.

Key results

  • In 2 trials, the proportion of patients achieving HbA1c
  • Head-to-head studies were also conducted of semaglutide vs sitagliptin (Januvia), empagliflozin (Jardiance), and liraglutide (Victoza) 1.8 mg
  • Semaglutide reduced HbA1C and also body weight (secondary endpoint).

Limitations

  • Oral semaglutide may increase risk for thyroid C-cell tumors and is not recommended as a first-line diabetes treatment.