FDA CRL - Biothera

The FDA issued a Complete Response Letter (CRL) to Conjupro Biotherapeutics, Inc. for its New Drug Application (NDA 218923) concerning irinotecan liposome injection. The agency determined the application cannot be approved in its current state, citing significant deficiencies.

A key issue identified was during a pre-approval inspection of a manufacturing facility, where significant observations (FDA 483) were made that adversely impact the facility's designated functions. Conjupro must ensure the facility provides satisfactory responses to these deficiencies, which need to be included in the company's complete resubmission. Additionally, Office of Study Integrity and Surveillance clinical inspections were deferred due to travel limitations and will be completed upon resubmission.

Other requirements include resubmitting the proposed proprietary name, which was conditionally acceptable, and providing a comprehensive safety update per 21 CFR 314.50(d)(5)(vi)(b). This update must detail any significant safety profile changes, incorporate new clinical data, present retabulations of adverse events, provide case reports for serious events, update exposure information, and summarize worldwide safety experience, including foreign labeling translations.

Under 21 CFR 314.110, Conjupro must resubmit the application, addressing all deficiencies, or take other actions such as requesting an extension or withdrawing the application, within one year. The product cannot be legally marketed until the application receives written approval.