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# FDA Extends Review of Novo Nordisk Hemophilia Therapy
- URL: https://www.fdaweb.com/fda-extends-review-of-novo-nordisk-hemophilia-therapy/
- Published: 2026-10-02T19:00:00.000Z
- Updated: 2026-10-02T23:18:57.000Z
- Author: David McFarland
- Tags: Biologics

FDA has extended the review of a Novo Nordisk BLA for denecimig for treating of hemophilia A, with or without inhibitors in adults and children. The agency did not provide a timeline for the extended review, according to the company. The previous user fee review action target date was set for the third quarter.

The BLA was originally submitted 9/2025\. “Following this submission, the FDA performed a pre-license inspection of the manufacturing site and provided feedback,” the company says. “Today, the FDA has informed Novo that the ongoing facility remediation activities are the cause for extension of the agency's review.”

The company notes that FDA has not identified deficiencies related to the clinical efficacy or safety data of denecimig demonstrated in the FRONTIER clinical trial program, which formed the basis og the BLA submission. “Novo is continuing implementation of the facility remediation activities in response to the FDA's feedback and is working closely with the agency to address the outstanding requirements,” it says. “The feedback on the manufacturing site does not impact other marketed Novo products.”

Denecimig is described as a FVIIIa mimetic bispecific antibody designed with the aim to deliver once monthly, every two weeks and weekly prophylaxis for people living with hemophilia A, with or without inhibitors. “Denecimig, which is administered under the skin, ‘mimics’ the role of FVIIIa by bridging factor IXa and factor X,” the company says. “This action mimics the cofactor function of FVIIIa, which helps restore the body’s thrombin generation capacity, helping blood to clot.”