FDA snubs Novo Nordisk's once-weekly semaglutide

Novo Nordisk (NOV: N) late Monday announced that the US Food and Drug Administration has issued a Refusal to File letter covering the label expansion application for once-weekly semaglutide 2.0mg 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. The news saw the Daish diabetes care giant’s shares dip 2.3% to 433.10 kroner by late afternoon today.

In the letter, the 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 program will be sufficient for approval of the label expansion application.