Skip to NavigationSkip to content

FDA approves Novo’s new type 2 diabetes pill

Published on 23/09/19 at 08:51am

A new drug from Danish drug maker Novo Nordisk, called Rybelsus (semaglutide), has been approved by the FDA for the use in patients with type 2 diabetes to lower blood sugar levels.

Rybelsus is the first drug in its class, called glucagon-like peptides (GLP-1), and is now approved for use in the United States. Before its approval the drug could only be injected.

Dr. Lisa Yanoof, Acting Director of the Division of Metabolism and Endocrinology Products at the FDA, said: “Before this approval, patients did not have an oral GLP-1 option to treat their type 2 diabetes, and now patients will have a new option for treating type 2 diabetes without injections.”

GLP-1 is a hormone found in low levels with people with type 2 diabetes. Rybelsus acts by slowing digestion and preventing the liver from making too much sugar, which in turn, assists the pancreas in producing more insulin.

Chief Scientific Officer at Novo Nordisk, Mads Korgsgaard Thomsen, added: “This ability to now deliver a new GLP-1 and harness the power of a biological medicine in a single, once-daily tablet – that is a unique thing. It’s never happened before [and] it’s a bit like a holy grail.”

The approval comes on the back of vast amount of positive data from the company’s Pioneer clinical trial programmes.

Rybelus has also outperformed numerous medications in efficacy such as Eli Lilly and Boehringer Ingelheim’s SGLT2 medication Jardiance, as well as Merck’s DPP-4 Januvia.

Novo Nordisk did not disclose what it plans to charge for the new oral treatment but said it would be “competitively priced” with other drugs in the same GLP-1 class of medicines.

Nik Kiran

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches