Novo Nordisk's oral semaglutide, Rybelsus, has received an important label update from the U.S. FDA, allowing it to be used as a first-line treatment for adults with type 2 diabetes who have not previously received diabetes treatment. This update removes a previous limitation of use that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes.
(Pic link
https://www.thepharmaletter.com/article/first-oral-biologic-rybelsus-continues-to-gather-pace)
Rybelsus was initially approved by the FDA in 2019 and is the first and only GLP-1 analog available in pill form. It is indicated, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes. By removing the previous limitation of use, Rybelsus can now be used earlier in the diabetes treatment journey, providing people living with type 2 diabetes with an additional option.
Rybelsus works differently than other diabetes pills, lowering blood sugar in three ways:
by increasing the release of insulin from the pancreas when blood sugar is high;
decreasing the release of sugar from the liver;
and slowing the process of food leaving the stomach after eating.
Rybelsus is a unique co-formulation of semaglutide and an absorption enhancer called SNAC (sodium N-(8-[2-hydroxybenzoyl] amino) caprylate), which facilitates absorption of semaglutide in the stomach, making it possible to provide semaglutide as a pill. Hooray, a lot of tech dev in the delivery!
Novo Nordisk is working with health insurance providers to ensure broad insurance coverage and patient access to Rybelsus. Eligible, commercially insured patients may pay as little as $10 for a one- to three-month prescription of this medicine.
Positive results from a ongoing phase IIIb study evaluating the efficacy and safety of Rybelsus were recently announced by Novo Nordisk. The study, called PIONEER PLUS, aimed to compare the efficacy and safety of Rybelsus at doses of 50mg, 25mg, and 14mg in patients with type 2 diabetes who had previously received treatment with other oral glucose-lowering drugs. The study lasted 68 weeks, with the primary endpoint being the change in glycated hemoglobin levels (HbA1c) in patients at weeks 52 and 68.
The results showed that, when evaluated from a trial medication perspective (all patients adhered to Rybelsus treatment without the need for other type 2 diabetes medications), the 25mg and 50mg doses of Rybelsus were more effective in reducing HbA1c compared to the 14mg dose at week 52. Additionally, patients in the Rybelsus 25mg and 50mg groups experienced significant weight loss.