Complete Response for CAM 2029 (octreotide) to treat acromegaly
Camurus announced that the FDA has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM 2029 (octreotide) extended-release injection for the treatment of patients with acromegaly
The CRL is attributed to facility-related deficiencies identified during a Current Good Manufacturing Practices (cGMP) inspection of a third-party manufacturer completed in September 2024. FDA has communicated that its determination of responses from the facility as satisfactory is needed for a timely resolution of the CRL and approval of the NDA. The CRL did not state any other concerns, including related to clinical efficacy or safety of CAM 2029.
“The CRL is disappointing, however, we are confident in the data supporting our NDA and the potential of CAM 2029 to address unmet medical needs of patients with acromegaly”, says Fredrik Tiberg, Camurus’ President & CEO. “Camurus is committed to working with the FDA and the third-party manufacturer to bring CAM 2029 to patients living with acromegaly as soon as possible.”
Labelling discussions with the FDA were held during the final stage of the NDA review and the prescribing information for CAM 2029 is well advanced.
In parallel with the US NDA process, a Market Authorization Application for CAM 2029 for the treatment of acromegaly is under review in the EU. In addition, two development programs for CAM 2029 for treatment of gastroentero- pancreatic neuroendocrine tumors and polycystic liver disease are progressing. The CRL does not impact on the advancement of these programs.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.