The FDA approved semaglutide (Ozempic) from Novo Nordisk on 12/5/17, after the Endocrinologic and Metabolic Drugs Advisory Committee recommended the drug in a 16-0 vote in mid-October. Semaglutide is a once-weekly glucagon-like peptide (GLP)-1 agonist for the treatment of type 2 diabetes. The drug is entering a crowded field and will compete with exenatide (Byetta/Bydureon), lixisenatide (Lyxumia), albiglutide (Tanzeum), dulaglutide (Trulicity) and Novo's own liraglutide (Victoza, Saxenda). While a weekly dosing schedule is an attractive benefit for semaglutide, the real game changer will be the availability of the drug as the first oral GLP-1 in 2-3 years. A 31-week, 632 patient, Phase III dose ranging trial compared oral semaglutide to weekly injections of the drug. HbA1c was lowered 0.9 to 1.9% with the oral doses compard to a 1.9% decrease with the injection. The 40mg oral dose had a similar decrease in HbA1c and weight compared to the injection. Adverse reactions were also similar.
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