# FDA CRL - Novo Nordisk Inc. - Unknown Date

Source: https://www.keypedia.com/records/crl/novo-nordisk-inc/0f634d95-f66d-4c38-b613-2e1611f779da

> FDA CRL for Novo Nordisk Inc. on Unknown Date. Product: BLA. Access full analysis and detailed observations.

---

## Details

- Record Type: CRL
- Company Name: Novo Nordisk Inc.
- Product Type: BLA
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Complete Response Letter (CRL) to Novo Nordisk Inc. regarding its Biologics License Applications (BLA) 761326/Original 1 and BLA 761326/Original 2 for NNC0148-0287 injection. The agency determined that the applications cannot be approved in their current form, citing several deficiencies under the BLA regulatory framework.

A primary concern for both applications stems from deficiencies identified during a pre-license facility inspection. Novo Nordisk is required to ensure the facility provides satisfactory responses to the FDA Form 483 findings, including submitting the response dates, with potential for re-inspection.

Specific to BLA 761326/Original 1 for type 1 diabetes, the FDA found an unfavorable benefit-risk balance. Clinical data revealed an unacceptably higher risk of clinically meaningful hypoglycemia (50% higher incidence, 80% higher event rate) compared to a daily basal insulin comparator, without showing superior HbA1c reduction or other patient benefits. This increased risk was linked to the dosing and titration algorithm used in the ONWARDS 6 study.

To address these issues, Novo Nordisk must submit new clinical data demonstrating a favorable benefit-risk profile for NNC0148-0287 in type 1 diabetes patients, and is advised to request a meeting to discuss a new study to optimize dosing. Additionally, a comprehensive safety update and resubmission of the proprietary name are required. Revisions to prescribing information are also pending.

## Related Documents

- [CRL - Unknown Date](https://www.keypedia.com/records/crl/novo-nordisk-inc/3022b96d-6f06-447d-ada4-c289cf70516c)
- [483 - 2025-01-13](https://www.keypedia.com/records/483/novo-nordisk-inc/a0a57c04-1ff0-4790-b27f-58900467be71)
- [483 - 2025-02-07](https://www.keypedia.com/records/483/novo-nordisk-inc/af90a225-6f09-44bf-9f09-4154f6541ff1)
- [WARNING_LETTER - Unknown Date](https://www.keypedia.com/records/warning_letter/novo-nordisk-inc/db2f6fbc-f41a-43dc-8048-8b4700e3299a)
- [WARNING_LETTER - 2025-02-07](https://www.keypedia.com/records/warning_letter/novo-nordisk-inc/4c65dec7-7407-4a4c-8764-78d75a4bdadf)

## Related Officers

- [Helen Chen, MSc, RAC](https://www.keypedia.com/people/helen-chen-msc-rac/96a357d8-ba13-4013-9ea8-5a4e42cdd6d0)

Company: https://www.keypedia.com/companies/novo-nordisk-inc/920bb4ea-9450-45a6-bcd7-9f85c2f2bbad

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c