FDA Issues Complete Response Letter to Camurus for Acromegaly Treatment Due to Third-Party Manufacturing Deficiencies

FDA Decision:
The FDA issued a Complete Response Letter (CRL) to Camurus for its new drug application (NDA) for CAM2029, a treatment for acromegaly, due to facility-related deficiencies at a third-party manufacturer.

Reason for CRL:
The CRL was attributed to issues identified during a Current Good Manufacturing Practices (cGMP) inspection of the third-party manufacturer completed in September 2024.

No Clinical Concerns:
The CRL did not mention any concerns related to the clinical efficacy or safety of CAM2029.

Next Steps:
Camurus will work with the FDA and the third-party manufacturer to resolve any outstanding observations and bring CAM2029 to market as soon as possible.

Parallel EU Review:
A Market Authorization Application for CAM2029 is under review in the EU, and the CRL does not impact the advancement of other development programs for CAM2029.