Approval Letter Other 761151 (Jan 1, 2023)

Summary

This is a Complete Response letter from the FDA to UCB, Inc. regarding their Biologics License Application (BLA) 761151 for UCB4940 (CDP4940). The FDA has determined that the application cannot be approved in its present form due to deficiencies related to facility inspections and product quality. The letter outlines specific requirements for resubmission, including resolving facility inspection deficiencies, resubmitting the proprietary name, and providing a comprehensive safety update.

Key points

• Satisfactorily resolve deficiencies identified during the inspection of the UCB Pharma SA manufacturing facility.
• Resubmit the proposed proprietary name (Bimzelx) when responding to the application deficiencies.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• The safety update must describe in detail any significant changes or findings in the safety profile.
• The safety update must incorporate new safety data into sections describing discontinuations due to adverse events, serious adverse events, and common adverse events, using the same format as the original submission.
• The safety update must present tabulations of the new safety data combined with the original application data.
• The safety update must include tables that compare frequencies of adverse events in the original application with the retabulated frequencies.
• The safety update must provide separate tables for the frequencies of adverse events occurring in clinical trials for indications other than the proposed indication.

Cited reasons

• Unresolved Manufacturing Facility Deficiencies
• Proprietary Name Resubmission Required
• Inadequate Safety Update and Data Presentation
• The application received a Complete Response due to unresolved manufacturing facility deficiencies, the need to resubmit the proprietary name, and extensive requirements for a comprehensive safety data update, including clinical, nonclinical, and worldwide experience.

Recommended actions

• Satisfactorily resolve deficiencies identified during the inspection of the UCB Pharma SA manufacturing facility.
• Resubmit the proposed proprietary name (Bimzelx) when responding to the application deficiencies.
• Include a safety update as described at 21 CFR 314.50(d)(5)(vi)(b) when responding to deficiencies.
• The safety update must describe in detail any significant changes or findings in the safety profile.
• The safety update must incorporate new safety data into sections describing discontinuations due to adverse events, serious adverse events, and common adverse events, using the same format as the original submission.
• The safety update must present tabulations of the new safety data combined with the original application data.
• The safety update must include tables that compare frequencies of adverse events in the original application with the retabulated frequencies.
• The safety update must provide separate tables for the frequencies of adverse events occurring in clinical trials for indications other than the proposed indication.

Deficiency summary

The application received a Complete Response due to unresolved manufacturing facility deficiencies, the need to resubmit the proprietary name, and extensive requirements for a comprehensive safety data update, including clinical, nonclinical, and worldwide experience.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

BLA under section 351(a) of the Public Health Service Act

Impact

Impact score

0.95

Estimated delay

270 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

Critical manufacturing quality system deficiencies, administrative requirements for proprietary name resubmission, and extensive requirements for a comprehensive safety data update, including clinical, nonclinical, and worldwide experience, led to the Complete Response.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%