First Oral GLP-1 Agonist Approved for Diabetes
The FDA recently approved oral Rybelsus® (semaglutide), a once daily pill available as 7 mg and 14 mg for the treatment of type 2 diabetes in adults. This is the first, and only, glucagon-like peptide-1 (GLP-1) analog available in pill form. The once-weekly injectable version of the GLP-1 receptor agonist, Ozempic®, has been approved since December 2017. Warnings for Rybelsus are similar to Ozempic, excluding the injection site reactions.
One of the biggest barriers to using GLP-1 agonists has been the requirement to be in injectable form for efficacy. Rybelsus® is likely to be a game changer in type 2 diabetes treatment. As a drug class in general, GLP-1 agonists have an average A1c lowering of ~1.5% and ~5lbs of weight loss. The injectable semaglutide has shown an even higher average weight loss of 8.8 lbs.
Rybelsus® was studied in 10 PIONEER clinical trials and is expected to be available in the U.S. beginning in Q4 2019. Health plan drug formulary changes can be expected to be updated in January 2020.