The US Food and Drug Administration (FDA) has approved its first oral GLP-1 receptor protein: Novo Nordisk’s Rybelsus (semaglutide).
Last week, Rybelsus became the first oral glucagon-like peptide (GLP-1) receptor protein treatment approved in the US as a non-insulin treatment for people with type 2 diabetes.
The drug, marketed and made by Danish drugmaker Novo Nordisk, is used to increase the amount of insulin that the pancreas releases in response to food. The firm already has an approved subcutaneous semaglutide product marketed under the brand Ozempic, but the once-daily oral brings a new option for adults with type 2 diabetes.
The US Food and Drug Administration (FDA) described the drug as “a new option for treating type 2 diabetes without injections,” and welcomed the product as part of its pledge to support “the advancement of new therapeutic options that can make it easier for patients to control their condition.”
According to spokesperson Mette Kruse Danielsen, Rybelsus will be made available to adults with type 2 diabetes in the US in the fourth quarter of 2019.
While Danielsen did not comment on Novo Nordisk’s capacity plans, she told this publication the firm has a robust network of production facilities it has been investing in to support the product.
“Novo Nordisk plans to rebuild a facility in Treyburn, North Carolina to support the production of Rybelsus in the US market. The plant will be responsible for the tableting and packaging of Rybelsus, and future oral products, supporting its nearby production site in Clayton in the US, along with its production facility in Denmark.”
The Treyburn facility was acquired by Novo Nordisk in August from OxyContin maker Purdue Pharma. At the time the firm told Bioprocess Insider “significant rebuilding is needed” to convert the site, and: “After that follows months of testing and run-in before we are ready to apply for FDA approval of the plant.”