Rybelsus is currently being reviewed by various regulatory agencies across the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency
Image: The US FDA has approved Rybelsus for once-daily use in 7mg and 14mg therapeutic doses. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
Denmark-based pharmaceutical company Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved Rybelsus (semaglutide) tablets 7mg or 14mg for adults with type 2 diabetes, along with diet and exercise may improve blood sugar (glucose).
Novo Nordisk said that its Rybelsus marks the first and only glucagon-like peptide-1 (GLP-1) analog available in the form of pills and provides a new option for adults with type 2 diabetes.
PIONEER clinical trial investigator Vanita R Aroda said: “GLP-1 receptor agonists are effective medications for people with type 2 diabetes but have been underutilized in part because they have, until now, only been available as an injectable treatment.
“The availability of an oral GLP-1 receptor agonist represents a significant development and primary care providers, specialists and patients alike may now be more receptive to the use of a GLP-1 therapy to help them achieve their blood sugar goals.”
Rybelsus is under review by various regulatory agencies across the world
The Type 2 diabetes is a public health issue in which, characterised by adult patients with poorly managed blood sugar capable of increasing the risk of developing serious diabetes-related complications.
The company said that the FDA has approved its Rybelsus based on results from 10 PIONEER clinical trials evaluating Rybelsus vs. sitagliptin, empagliflozin and liraglutide, enrolling 9,543 participants.
In addition, the clinical trials showed that Rybelsus has reduced A1C and, reduced body weight as a secondary endpoint.
The US FDA has approved Rybelsus with once-daily use in 7mg and 14mg therapeutic doses indication, and is expected to be available in the US from the fourth quarter of 2019.
Novo Nordisk intends to supply the Rybelsus initially from its manufacturing facilities in Denmark, and is planning the future supply from manufacturing facilities in the US.
The company said that the US FDA is still reviewing its new drug application (NDA) for Rybelsus seeking an additional indication to reduce the risk of major adverse cardiovascular events including heart attack, stroke, or cardiovascular death in adult type 2 diabetes, and cardiovascular disease (CVD) patients.
In addition, Rybelsus is currently being reviewed by various regulatory agencies across the world, including the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
Novo Nordisk US vice-president and chief medical officer Todd Hobbs said: “People living with type 2 diabetes deserve ore innovation, research and support to help them achieve their individual A1C goals.
“With Rybelsus, we have the opportunity to expand use of effective GLP-1 receptor agonist therapy by providing adults with type 2 diabetes an oral medication which was previously only available as an injection to help with managing their blood sugar.”