FDA Sends Novo Nordisk Complete Response Letter for Hemophilia Drug Concizumab

The FDA sent a complete response letter (CRL) to Novo Nordisk on April 24, requesting more information on the company’s hemophilia drug concizumab, the company announced in its first quarter earnings report.

In August 2022 the company submitted concizumab, an anti-tissue factor pathway inhibitor antibody, for regulatory approval for treatment of hemophilia A and B with inhibitors.

The agency is requesting information on the monitoring and dosing of patients to ensure that concizumab is being administered as intended, as well as further information on the manufacturing process, the company said.

Novo Nordisk also said it is evaluating the content of the CRL and will work with the FDA to provide the requested data.

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