Novo Nordisk has received a refusal to file letter from the US Food and Drug Administration (FDA) for a label expansion application for semaglutide.
The application, filed on 20 January 2021, is seeking an expanded approval for once-weekly semaglutide 2.0mg for the treatment of type 2 diabetes.
In a statement, Novo said that the FDA has requested additional information, including data relating to a proposed new manufacturing site, in its letter.
The company added that it believes the already completed clinical trial programme will be ‘sufficient’ for approval of the label expansion application.
The FDA initially approved oral semaglutide under the brand name Rybelsus in September 2019, making it the first glucagon-like peptide (GLP-1) receptor protein treatment approved in the US that does not need to be injected.
Novo is expecting to resubmit the application for once-weekly semaglutide to the FDA in the second quarter of 2021.
