Novo Nordisk today announced that the US Food and Drug Administration (FDA) has issued a Refusal to File letter covering the label expansion application for once-weekly semaglutide 2.0 mg for the treatment of type 2 diabetes which was filed on 20 January 2021. A refusal to file letter is received when the FDA determines additional information is required to review a complete application.
In the letter, FDA has requested additional information including data relating to a proposed new manufacturing site. While additional information needs to be included in the resubmission, Novo Nordisk believes the already completed clinical trial programme will be sufficient for approval of the label expansion application.
Novo Nordisk expects to resubmit the application to FDA during the second quarter of 2021.