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# FDA Novo Nordisk Concizumab Complete Response Letter
- URL: https://www.fdaweb.com/fda-novo-nordisk-concizumab-complete-response-letter/
- Published: 2023-05-04T12:00:00.000Z
- Updated: 2026-09-14T18:29:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154377

FDA has issued a complete response letter to Novo Nordisk for its concizumab anti-tissue factor pathway inhibitor antibody, asking for additional information related to the monitoring and dosing of patients to ensure that the product is administered as intended. FDA also wants more information on the manufacturing process. Company officials said on a 5/4 [earnings call](https://edge.media-server.com/mmc/p/uxrg6ena/?ref=fdaweb.com) that they will work closely with the agency to provide the requested data.

In 2020, FDA halted concizumab trials over reports of blood clots in three patients. The studies resumed five months later after the company developed a mitigation strategy that it says has led to no additional thrombotic events after the trials resumed.