Novo Nordisk resubmits application for Awiqli weekly basal insulin to FDA

[Novo Nordisk sign on building, Danish pharmaceutical healthcare giant, production innovative drugs, obesity treatment Ozempic, pharmaceutical company innovation, Mainz, Germany June 15, 2024]
Victor Golmer

* Novo Nordisk (NVO [https://seekingalpha.com/symbol/NVO]) has resubmitted a Biologics License Application for its once-weekly basal insulin Awiqli (insulin icodec).
* The application is supported by results from the phase 3 ONWARDS trial which enrolled about 4,000 individuals with type 2 diabetes.
* If approved, Awiqli could become [https://www.prnewswire.com/news-releases/novo-nordisk-resubmits-awiqli-to-the-fda-with-potential-to-be-the-first-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes-302568645.html] the first weekly basal insulin therapy in the US.
* Novo was issued [https://seekingalpha.com/news/4123732-novo-nordisk-once-weekly-insulin-rejected-fda] a complete response letter in July 2024 for Awiqli, with the US FDA asking for more information related to its manufacturing process and a type 1 diabetes indication.

MORE ON NOVO NORDISK

* Novo Nordisk: Wegovy Sales Soar, Trump Tariffs No Threat [https://seekingalpha.com/article/4826144-novo-nordisk-wegovy-sales-soar-trump-tariffs-no-threat]
* Novo Nordisk: Don't Be Deterred By Outlook Downgrades [https://seekingalpha.com/article/4824409-novo-nordisk-dont-be-deterred-by-outlook-downgrades]
* Novo Nordisk: Attractive Buying Opportunity In A Distracted Market [https://seekingalpha.com/article/4824271-novo-nordisk-attractive-buying-opportunity-in-a-distracted-market]
* Pharma lobbying group to launch site to connect consumers to discount drugs [https://seekingalpha.com/news/4499841-pharma-lobbying-group-launch-site-connect-consumers-discount-drugs]
* Novo Nordisk submits haemophilia treatment application for review to FDA [https://seekingalpha.com/news/4499824-novo-nordisk-submits-haemophilia-treatment-application-for-review-to-fda]